Glossary

(EMR) - digital version of a medical chart that contains all of a patient’s medical history from one provider or facility.

early stages of a developing organism, broadly used to refer to stages immediately following fertilization of an egg through implantation and very early pregnancy (i.e., from conception to the eighth week of pregnancy).

when an unapproved drug or device is used to treat a patient in an emergency situation in which no standard acceptable treatment is available and in which there is not sufficient time to obtain IRB approval. Emergency means life-threatening (drug & device), severely debilitating (drug), or serious disease or condition that needs immediate treatment (device).

a departure from the approved protocol without prior IRB approval that occurs in an emergency situation, such as when a departure from the protocol is required to eliminate apparent immediate hazard to the subject.

is a person who is hired for a wage, salary, fee or payment to perform work for an employer. Employees are individuals performing institutionally designated activities and acting on behalf of the institution or exercising institutional authority or responsibility.

in general, an institution is considered engaged in a particular non-exempt human subjects research project when its employees or agents for the purposes of the research project obtain: (1) data about the subjects of the research through intervention or interaction with them; (2) identifiable private information about the subjects of the research; (3) the informed consent of human subjects for the research; 4) whenever the institution receives a direct HHS award to support such research, even if all of the human subjects activities will be performed by agents or employees of another institution.

screened participants are enrolled if eligibility is verified (meet all inclusion criteria and none of the exclusion) and they consent to continue in the study.

the process of seeking eligible participants and obtaining their consent to participate in the research. Enrollment generally starts with recruitment, leading to screening for eligibility, and consent to enroll in the study.

The Epic web-based EMR portal that allows secure access to select patient information for designated users.

fair or just; used in the context of selection of subjects, to indicate that the benefits and burdens of research are fairly distributed.

Velos eResearch is UT Health San Antonio's designated Clinical Trial Management System (CTMS). Velos eResearch is a web-based application designed to centralize the management tasks needed to conduct a clinical trial including study statuses, subject enrollment and activity, study calendars, budgets and billing.

The humane destruction of an animal accomplished by a method that produces rapid unconsciousness and subsequent death without evidence of pain or distress, or a method that utilizes anesthesia produced by an agent that causes painless loss of consciousness and subsequent death (AWR).

a member by virtue of the office held by the individual.

a one-time, intentional action that departs from the IRB approved protocol for a single subject. An exception is identified before it occurs and is under the control of the investigator.

Examples include (but are not limited to): enrollment of a single subject who does not meet all eligibility criteria for a study, but the investigator and sponsor have agreed this subject should be enrolled. 

research that meets the regulatory definition of human subjects research and qualifies for exemption.

data in the records or on the shelf prior to IRB review and was created for a reason other than the proposed research. All data included in the request to analyze existing data must exist at the time the research is proposed.

specimen on the shelf prior to IRB review and was created for a reason other than the proposed research. All speciments included in the request to analyze existing specimens must exist at the time the research is proposed.

use of an investigational (unapproved) drug or device when the primary purpose is to diagnose, monitor, or treat a patient's disease or condition. The distinction between expanded access and the use of an investigational drug (or device) in research covered under an IND/IDE is that expanded access uses are not primarily intended to obtain information about the safety or effectiveness of a test article. Although not considered research, the FDA requires IRB approval prior to non-emergency use.

review process when one or more a designated IRB member review a business item instead of at a convened meeting of the board.

term often used to denote an intervention (e.g., drug, device, procedure.) that is unproven or scientifically yet to be validated with respect to safety and efficacy. Often used to denote FDA approval has not yet been obtained. A procedure may be considered experimental without necessarily being part of a formal study (research) to evaluate its usefulness.

The scientific aims and objectives of the study. Experimental endpoints are used to determine when animals have completed the study, and can be transferred or euthanized.

Materials such as drugs, fluids, or sutures that have exceeded the to be used by date or expiration date.

when one has unfair advantage over another. Often raised as a concern when paying (offering inducements to) vulnerable populations (e.g., economically disadvantaged or institutionalized individuals). Paying economically disadvantaged individuals the same amount as would be paid to others who are not disadvantaged may be seen as unduly influential. However, paying these individuals less to reduce undue influence may be seen as exploitative.

An IRB operated by an organization other than UTHealthSA

adverse events and unanticipated problems experienced by subjects enrolled by investigator(s) at an institution not affiliated with UTHSCSA.