Glossary

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.

is a record of all of the protocol information or data to be reported on each participant.  

Information captured in a CRF must be supported by a Source Document (unless the CRF is the source document).

Confidential Disclosure Agreement is a legal contract that protects proprietary information and binds the parties to hold information in confidence for a set period of time. CDAs may be titled as a Nondisclosure Agreement (NDA), or Secrecy Agreement when received from an outside institution.

protects the privacy of research subjects by prohibiting disclosure of identifiable, sensitive research information to anyone not connected to the research except when the subject consents or in a few other specific situations. CoCs protect against compulsory legal demands, such as court orders and subpoenas, for identifying information or identifying characteristics of a research participant. Effective October 1, 2017, all research that was commenced or ongoing on or after December 13, 2016 and is within the scope of Notice of Changes to NIH Policy for Issuing Certificates of Confidentiality is automatically issued a CoC.  CoCs issued in this manner will not be issued as a separate document. Researchers can request a CoC from NIH for health-related studies that are not funded by HHS by submitting a request here: https://grants.nih.gov/policy/humansubjects/coc/how-to-apply.htm

a person who has not attained the legal age of majority under the applicable law of the jurisdiction in which the research will be conducted (18 years in the state of Texas), and therefore as a general rule cannot consent to treatment or procedures involved in research.

academic projects or student assignments involving collection of data from human subjects, when the data is used solely for the purpose of teaching course content and not intended to be used to develop or contribute to generalizable knowledge.

in the interest of national security, federally funded research can be 'classified' in terms of limited access to data, information, and facilities (inputs) that may be required to carry out the research or in terms of the limited distribution of the results of the research (outputs).

a debit card used to pay participants.  ClinCard is the preferred method of participant payment because the ClinCard software provides the financial safeguards required by UTHSA.

genuine uncertainty on the part of the expert medical community about the comparative therapeutic merits of two or more treatment strategies.

involves the use of a test article (i.e., drug, device, food substance or biologic) and one or more human subjects. This applies to test articles that require prior submission to the FDA and those that do not if the results of the investigation are intended to be part of an application to the FDA for a research or marketing permit. It does not include the use of FDA approved devices or drugs in routine medical practice.

animal manipulations or interventions used for: (1) the clinical prevention or treatment of illness, disease or injury; (2) to prevent or reduce/eliminate animal pain or distress (such as anesthesia or analgesia); or (3) euthanasia

the broad category of biomedical or health outcome research designed to assess pre-defined groups of individuals.

include clinical care, clinical tests or clinical procedures that are delivered as part of healthcare (i.e. delivered by professional and technical staff in a clinic, hospital, laboratory, research center, etc.).

one type of Clinical Research that follows a pre-defined plan or protocol. Subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

animal manipulations or interventions used for: (1) the clinical prevention or treatment of illness, disease or injury; (2) to prevent or reduce/eliminate animal pain or distress (such as anesthesia or analgesia); or (3) euthanasia

designated by the PI and approved by the IRB to assist with local PI responsibilities (e.g., report unanticipated problems, authorize modifications or progress reports).

rules published in the Federal Register by the executive departments and agencies of the Federal Government.

indicates when: (1) identifying information (such as name or social security number) that would enable the investigator to readily ascertain the identity of the individual to whom the private information or specimens pertain has been replaced with a number, letter, symbol, or combination thereof (i.e., the code); and (2) a key to decipher the code exists, enabling linkage of the identifying information to the private information or specimens.

occurs when an overt threat of harm is intentionally presented by one person in order to obtain compliance from another. To be coercive, a subject who refuses must be made worse off than if he or she would have been, if never asked even if the harm is only perceived.

Coercion occurs, for example, in cases where retribution is conceivable or perceived by the subject. Examples of coercion include situations where it is implied that continued services are dependent upon participation in the research; or where refusal may affect some future care or outcome. (Inducements (including payments) are not considered coercion for the purposes of UTHSCSA IRB applications of policy. See Undue Influence concerning when judgment may be compromised by financial incentives especially when the subject is not the recipient of the financial incentive).

The IRB must eliminate all sources of coercion.

disorders or conditions that affect cognitive or emotional functions to the extent that capacity for judgment is significantly diminished may be considered to have Impaired Decision-Making Ability.

While having either a psychiatric disorder (e.g., psychosis, neurosis, personality, or behavior disorder), a developmental disorder (e.g., mental handicapped), or a neurological disorder that affects cognitive or emotional functions to the extent that capacity for judgment is significantly diminished may be considered to have a Impaired Decision-Making Ability, cognitively impaired should not be automatically considered to be unable to provide valid consent or assent. Additionally, other individuals may be also be considered by the PI or the IRB to be cognitively-impaired or have a Impaired Decision-Making Ability or have limited decision-making ability because they are under the influence of drugs or alcohol, suffering from degenerative diseases affecting the brain, are terminally ill, or have disabling physical handicaps, depending on the circumstances.

is not an employee or agent of a HSC-IRB affiliated institution and must be conducting the collaborative research activities outside the facilities of the affiliated institution(s). There are two types of collaborating individual investigators:
1) collaborating independent investigator is not acting as an employee of any institution with respect to his or her involvement in the research being conducted by the assured institution(s).
2) collaborating institutional investigator is acting as an employee or agent of a non-assured institution with respect to his or her involvement in the research being conducted by the assured institution and the non-assured institution that does not routinely conduct human subjects research.

anyone who obtains data or specimens from the source and provides it to the research (e.g., registry/repository for storage).

a collaborative research approach that is designed to ensure and establish structures for participation by communities affected by the issue being studied, representatives of organizations, and researchers in all aspects of the research process to improve health and well-being through taking action, including social change.

the offical term is "Expanded Access" to investigational drugs or devices for treatment. The primary purpose is to diagnose, monitor, or treat a patient's disease or condition.

is payment for participation in research and should be the same for each subject as opposed to reimbursement which may be different for each subject if for example reimbursement is based on verification of travel expenses, etc.

compensation paid to others for recruitment and screening related activities that are unrelated to whether the participant ultimately enrolls in or completes the research study (such as advertising, administrative and personnel costs) or compensation for the costs of services provided to those individuals who do ultimately enroll.

a legal term, used to denote capacity to act in 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.

indicates that the local site may enroll more subjects than originally planned by the study sponsor. In this situation, the total number of subjects enrolled study-wide does not change.

indicates that all study procedures, research related interactions, and acquiring the subject's Private Identifiable Information were completed as planned. The subject is no longer participating in the research

Confidential Disclosure Agreement is a legal contract that protects proprietary information and binds the parties to hold information in confidence for a set period of time. (AKA Nondisclosure Agreement/NDA).

pertains to the treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others in ways that are inconsistent with the understanding of the original disclosure, without permission.

a situation in which the time or effort that a UT Health San Antonio employee devotes to outside professional activities directly or significantly interferes with the fulfillment of the employee's responsibilities, or (b) when an employee receives in excess of 30% of their institutional base salary in consideration for outside activities, or (c) when the employee uses State property or other resources without authority in connection with the employee's outside employment, board service, or other activity.

refers to situations where the individual has the opportunity to influence the Health Science Center's business, administrative, academic, research, clinical, or other decisions in ways that could lead to personal financial gain or advantage or could appear to cause bias in the design, conduct, or reporting of research or educational activities.

is a person's voluntary agreement to participate in research.

an identified individual who have been appropriately consented and are awaiting screening

an unofficial advisor who is not authorized to act on behalf of the committee or person being advised.

a pattern of recurring (in one or more protocols simultaneously or over a period of time) or ongoing instances of actions or omissions (noncompliance) which indicate: 1) an underlying deficiency in knowledge of the regulations and IRB requirements or; 2) a possible inability or unwillingness to comply with them.

designates the review of requests to re-approve a study for continuation at any time after initial approval is granted.

this includes clinical items and services typically provided, absent the research, by professional and technical staff in a clinic, hospital, laboratory, research center, etc. This does not include any items or services that are performed more often than would otherwise be considered acceptable practice. A bill or claim is typically generated for these items and services.

when HSC investigators are engaged in research or the HSC will receive a direct federal award to conduct human subjects research, even where all activities involving human subjects are carried out by a non-HSC entity (e.g., subcontractor or collaborator).

are Health plans, health care clearinghouses and health care providers who come into possession of protected health information in connection with a transaction that is subject to federal HIPAA requirements

Clinical Trial Agreement is one of several key documents that govern the conduct of clinical trials. CTAs serve as a legally binding contract between a sponsor, performance site, and researcher, and outline each party's responsibilities and obligations for the clinical trial.

Key features of CTAs:

• Agreement parties
• Indemnification
• Confidentiality
• Publication
• Intellectual property
• Insurance
• Governing law
• Budget
• Scope of work (generally the protocol)

a special device, not generally available or used, intended for use by an individual patient ordered by a physician or dentist.

refers to surveys of program users to obtain feedback for use by program managers.