the process of seeking eligible participants and obtaining their consent to participate in the research.See also: Enrollment, Subject Statuses
indicates receipt of a communication, document or memo that does not, according to applicable regulations or policy, require formal approval.
applicable to non-interventional studies, indicates participant is actively involved with study intervention(s) or interaction(s).See also: Subject Statuses
applicable to interventional study, indicates participant is actively involved with study intervention(s) (including the intervention of being tested or evaluated).See also: Subject Statuses
a modification to an approved application which does not require IRB or IACUC approval (as applicable).
Examples include (but are not limited to):
Addition of a substance that is used as an addition to another substance.
any untoward or unfavorable medical occurrence in a research subject (e.g., physical or psychological harm), including any abnormal sign, symptom, or disease, temporally associated with the subject's participation in the research, whether or not it is considered related to the subject's participation in the research.See also: Related Adverse Event, Serious Adverse Event
any institution that relies on the HSC IRB or IACUC.
A chemical compound, drug, reagent or biologic.
used to indicate when an individual is working on behalf of the institution (i.e., performing designated activities or exercising delegated authority or responsibility) in relation to research. An agent can be an employee of the institution (e.g., faculty or staff) or a non-employee who is authorized by the institution to act on behalf of the institution (e.g., student, affiliated faculty, emeritus professors).
It is possible for a HSC employee to conduct research and not be considered an agent of the university if the research is conducted during non-official duty time, is not in connection with her/his HSC responsibilities, is not being conducted at a HSC facility and the research is not supported by a direct HHS award to the HSC (review the HSC Handbook of Operating Procedures (HOP) on Conflict of Commitment). The institution however generally reserves the right to determine for themselves whether their employee (in whole or in part) is performing institutionally designated activities and acting on behalf of the institution or exercising institutional authority or responsibility in regard to that research and the IRB will generally consider this in determining whether the institution in question is engaged in research.See also: Employee, Engaged in Research
an unproven assertion of noncompliance.See also: Noncompliance
a formal process for changing a previously approved IRB or IACUC application. Amendments require approval by the IRB or IACUC.See also: Major Change or Modification, Minor Change or Modification
abbreviation for the USDA's Animal and Plant Health Inspection ServiceSee also: USDA
appreciation payments are bonuses given after children's participation to thank them for their efforts. These are usually of no more than token value and may include non-cash items such as toys, event tickets, or gift certificates.See also: Children
official(s) determined by each organization to be points of contact for research. This may include an individual, an office or a committee. (This term should not be confused with another similar but distinctly different DHHS term Authorized Institutional Official).See also: Authorized Institutional Official
affirmative agreement by an individual not competent to give legally valid informed consent to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.See also: Competence, Informed Consent, Parental Permission
is a written document submitted by an institution that is engaged in non-exempt human subjects research conducted or supported by a federal agency.See also: Federal Wide Assurance
an institution holding an approved assurance from the applicable federal agency.See also: Assurance of Compliance
both physical attendance and attendance via teleconference so long as all members are connected simultaneously.See also: Quorum
an individual's written permission to allow a covered entity to use or disclose specified PHI for a particular purpose.
within an institution, the point of responsibility for the oversight of research and IRB functions.
persons who are authorized under Texas state law to make health care decisions on behalf of other individuals will also be personal representatives under HIPAA.
the ability of a person to consider alternatives, make choices, and act without undue influence or interference from others.
Examples of individuals with diminished autonomy may include: students or employees under the supervision of any investigator, prisoners, children, or patients under the care of a clinician who is the investigator.
ethical principles and guidelines for the protection of human subjects of research.
something that promotes or protects well-being, an advantage. Compensation cannot be considered a benefit.
Just as there are a range of harms: physical, social, economic, psychological, and legal, there can also be a range of benefits: physical benefit is clinically beneficial - as with standard-of-care procedures known to be helpful in guiding the subject's care when plans include using them as such (experimental procedures or procedures that must be verified by an approved device might not result in this benefit), notwithstanding that the subjects could have received the benefit without being in the study (this information comes to light in the alternatives description); psychological benefit of educational, informational, counseling or other resources provided in the study or empowerment. These can be directed at the individual (direct benefit, secondary benefit, monitoring benefit), the community or a general knowledge gained benefit (philanthropic on behalf of the individual). Only certain anticipated benefits may be considered appropriate for consideration to weigh against the probability of harm in certain populations and circumstances.
interventions which are: brief in duration; harmless, painless, not physically invasive; not likely to have a significant adverse lasting impact on the subjects; no reason to believe the subject will find the intervention offensive or embarrassing; or may include incomplete disclosure.See also: Exempt Human Subjects Research
The risk of making clinical billing errors.
Depending on the nature of the study, the clinical services can be billed to either the participant’s healthcare insurance or must be paid by the research. It is important to determine the appropriate payor for each study procedure before the study begins to avoid making clinical billing errors (i.e., “billing risk”).See also: Clinical Services, Research Only
a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, applicable to the prevention, treatment, or cure of a disease or condition of human beings.
removal of a piece of tissue from a live animal.
the abdominal, thoracic, cranial, synovial, or bone marrow cavities, i.e. those chambers not immediately associated with the outside world.
payments tied to the rate or timing of recruitment or performance or other aspects of a clinical study. Does not include compensation for recruitment services as long as the compensation is unrelated to whether the participant ultimately enrolls in or completes the research study.
a protocol in which animals are only bred for use in other protocols.
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.See also: Impaired Decision Making Ability, Incapacitated, Informed Consent
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).See also: 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.See also: Non-Regulated Research
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.See also: FDA Regulated Research
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.).See also: Service Provider
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.See also: Clinical Research, Interventional Study
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.See also: Inducements, Undue Influence
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.See also: Handicapped, Impaired Decision Making Ability, Mentally Disabled
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).See also: Repository
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.See also: Expanded Access
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.See also: Reimbursement
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.See also: Capacity, Handicapped, Impaired Decision Making Ability, Incompetent
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 researchSee also: Subject Statuses
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).See also: CDA
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 screeningSee also: Subject Statuses
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.See also: Noncompliance
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:
a special device, not generally available or used, intended for use by an individual patient ordered by a physician or dentist.See also: Device
refers to surveys of program users to obtain feedback for use by program managers.See also: Non-Regulated Research
facilities that collect, store, and distribute human data for research purposes. Data management activities involve three components: (i) the collectors of data; (ii) the data storage and management center; and (iii) the recipient investigators. Data management centers may be combined with a human repository.
when mortality is one of the experimental endpoints in animal research.
giving subjects previously undisclosed information about the research project following completion of their participation in the research.
intentionally misleading or withholding information about the nature of the experiment.
an international ethical code containing basic principles, which are similar to the Nuremberg Code, but represent an expansion of what constitutes acceptable research and the ethical responsibilities of investigators.
are one type of violation and include any condition of animal care or treatment that is not in compliance with the Animal Welfare Act (or its regulations and standards); or established by assurance, regulation, policy / procedure with other applicable entities.
animal use areas that are the responsibility of the Department or Institute Chair. This is a location outside of the DLAR managed vivarium that does not meet the minimum criteria for an animal housing area and the animals will held in the area for less than 12 hours and not overnight; must comply with IACUC Policy.
an experienced member designated by the Chair to review business items on behalf of the committee.
are one type of violation and include any variance in the research practices from originally IACUC approved proposal that adversely affect animal welfare.
a departure from the approved study protocol without prior IRB approval that: 1) is generally noted or recognized after it occurs, OR if identified before it occurs cannot be prevented by the investigator (not an intentional deviation); and 2) has no potential substantive effect on the risks to research participants, AND 3) has no substantive effect on the scientific integrity of the research plan or the value of the data, and did not result from willful or knowing misconduct on the part of the investigator(s).
an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: 1) recognized in the USPÐNF, OR 2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, OR 3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.
Department of Health and Human Services is responsible for Improving the health and well-being of America. The National Institutes of Health (NIH), Center for Disease Control (CDC), Health Resources and Services Administration (HRSA) and the Substance Abuse and Mental Health Services Administration are examples of DHHS agencies.
an identified individual who initially declines participation in research.See also: Subject Statuses
is a product taken by mouth that contains a "dietary ingredient" intended to supplement the diet. The "dietary ingredients" in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandular, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders.
behaviors that would indicate an individual does not want to participate.
A\animal use or housing areas that are the responsibility of the Department of Laboratory Animal Resources (DLAR). In these areas, DLAR 1) approves the species to be housed in the area, no matter whether the University has assigned the space to DLAR or a non- DLAR department, 2) charges per diem or technical fee for vertebrate species, 3) is financially responsible for minor maintenance and repairs, 4) is responsible for daily oversight of the animals when the area is actively in use (note that DLAR may delegate aspects of husbandry- including documentation of daily observation), 5) controls access to the area, and 6) approves any renovations, new construction, major HVAC changes, etc. to any part of the area prior to the start of the project. DLAR management must approve the use of a room prior to occupancy.
1) a substance recognized by an official pharmacopoeia or formulary; AND
2) a substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease; AND
3) a substance (other than food) intended to affect the structure or any function of the body; AND
4) a substance intended for use as a component of a medicine but not a Device or a component, part or accessory of a device.
Note: biological products are included within this definition and are generally covered by the same laws and regulations, but differences exist regarding their manufacturing processes (chemical process versus biological process).
that the product is useful in diagnosing, mitigating, treating or curing a specific disease or class of diseases.See also: Drug
(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.See also: Agent of the Institution
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.See also: Compassionate 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 UTHealthSASee also: Reviewing IRB
adverse events and unanticipated problems experienced by subjects enrolled by investigator(s) at an institution not affiliated with UTHSCSA.
Making up data or results and recording or reporting them. Fabrication is a form of research misconduct.See also: Falsification, Plagiarism, Research Misconduct
Manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record. Falsification is a form of research misconduct.See also: Fabrication, Research Misconduct
abbreviation for US Food and Drug Administration.
or cleared refers to FDA having issued premarketing approval (PMA) or cleared the device for marketing via a Premarket Notification 510(k).
if the research involves an FDA-regulated test article and the activity involves human participants.See also: Clinical Investigation
an institution's commitment to DHHS that it will comply with the requirements set forth in 45 CFR part 46, as well as the Terms of Assurance.
a developing human organism from the time of implantation until delivery; generally, refers to later phases of development.
financial information maintained to support accurate billing of clinical services associated with a research study.
an agency, organization, company, or person that pays for the trial.
compensation of any type (e.g. cash, cash equivalents, office or medical supplies, educational stipends, gift certificates, travel cost in excess of normal reimbursement costs, or anything else of value) to an individual made in exchange for referral or recruitment of a participant to a research study. This does not include compensation for services rendered which include screening and referral activity unrelated to whether the participant ultimately enrolls in or completes the research study.
noncompliance that is supported by a preponderance of evidence. A finding of noncompliance may exist because there is clear evidence, an admission supported by evidence, or an investigation into an allegation has determined the allegation to be supported by a preponderance of evidence.See also: Noncompliance
applicable to interventional study, indicates the participant has completed the intervention being tested as planned and is continuing with non-interventional procedures or other study interaction(s).See also: Subject Statuses
Complete - is a water in oil emulsion containing dried Mycobacterium butyricum which is used to enhance antigenicity and a greater immune response. (may be abbreviated as either: CFA or FCA)
universally or widely applicable knowledge.See also: Research
an individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care when general medical care includes participation in research.See also: Children
is a cessation of some or all research activities voluntarily initiated by the Principal Investigator or sponsor.
any person who has a physical or mental impairment that substantially limits one or more major life activities.
information, whether oral or recorded in any form or medium, that (1) is created or received by a health care provider, health plan, public health authority, employer, life insurer, school or university, 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.
abbreviation for The University of Texas Health Science Center at San Antonio or UT Health San Antonio
an ongoing part of the medical care and public health care functions closely integrated with timely dissemination of these data to those responsible for preventing and controlling disease or injury.See also: Non-Regulated Research
abbreviation for Health and Human Services (HHS) or the Department of Health and Human Services (DHHS)
Any location were vertebrate animals are maintained for more than 12 hours or overnight. The Guide defines minimum specifications including acceptable temperature and humidity ranges, appropriate light cycles, required security, sanitizable room surfaces, and HVAC requirements.
a clinical investigation (i.e., research study) using a humanitarian use device (HUD).See also: Clinical Investigation
a living individual about whom an investigator conducting research: 1) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; OR 2) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
research involving living individuals whenever the investigator obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens or interacts/intervenes for research purposes.See also: Human Subject, Research
criteria used to end experimental studies before all Experimental Endpoints have been met in order to avoid or terminate unrelieved pain and/or distress in animals. An important feature of humane endpoints is that they should be set with the goal of meeting the key study objectives even though the study is ended at an earlier point. Ideally, humane endpoints are sought that can be used to end studies before the onset of pain and distress. Humane endpoints are used to determine when animals can be removed from the study, treated, or euthanized.
an application to the FDA to market a Humanitarian Use Device (HUD), based on safety and probable benefit.
a Medical Device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects no more than 8,000 in the United States per year.
denotes the IACUC responsible for approval of a specific animal use protocol at a given institution.
Investigational Device Exemption filed with the FDASee also: Investigational Device Exemption, Investigational Devices
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.See also: Subject Statuses
UT Health San Antonio's application for disclosing outside professional activities including activities that could be Conflicts of Interest.See also: Conflict of Commitment, Conflict 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.See also: Emergency Use
diminished autonomy is present when an individual has either impaired decision-making ability or is subject to undue influence or control by others.See also: Assent, Capacity, Cognitively Impaired, Guardian, Incapacitated, Incompetent, Informed Consent, Mentally Disabled
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.See also: Assent, Capacity, Cognitively Impaired, Guardian, Incompetent, Informed Consent, Mentally Disabled
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.See also: Assent, Capacity, Cognitively Impaired, Guardian, Incapacitated, Informed Consent, Mentally Disabled
withholding information about the true purpose of the research.
Investigational New Drug application with the FDA.See also: Investigational New Drug
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.See also: Legally Authorized Representative, Legally Effective Informed Consent
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.See also: sIRB
confined, either voluntarily or involuntarily, in a facility for the care of the mentally or otherwise disabled.See also: Cognitively Impaired, Incapacitated, Incompetent, Mentally 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.See also: Human Subject
adverse events and unanticipated problems experienced by subjects enrolled by investigator(s) at an institution affiliated with UTHSCSA.See also: Unanticipated Problem Involving Risk to Subjects or Others
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.See also: Subject Statuses
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.See also: Subject Statuses
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.See also: Investigational Device Exemption
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.See also: New Drug Application
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.See also: Institutional Review Board, Reviewing IRB
term used in federal grant applications to include any individual responsible for the design, conduct, and reporting of research for a given study. Key personnel are subject to additional conflict of interest rules and reporting.
a person authorized either by statute or by court appointment to make health care decisions on behalf of another person who is, incompetent, or has impaired decision-making ability.See also: Informed Consent
consent of a subject, or if the subject is incapacitated, incompetent, or has impaired decision-making ability, then the consent of the subject's Legally Authorized Representative (LAR) or surrogate.See also: Informed Consent
diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted.See also: Emergency Use
a review process involving at least one member of the IRB that is required when determining research is exempt under 1) identifiable and sensitive educational tests, survey procedures, interview procedures, or observation of public behavior (46.104[d][iii]); OR 2) identifiable and sensitive benign behavioral interventions (46.104[d][i][c])See also: Exempt Human Subjects Research
any change that does not meet the definition of a minor change or modification to previously approved research, or a modification which fundamentally alters the judgments relied upon to make determinations on any of the criteria for IRB approval under 45CFR 46.111 and/or involves modifications which would not be eligible for expedited review.See also: Amendment
penetrates and exposes a body cavity or produce substantial impairment of physical or physiologic function OR involves extensive tissue dissection or transectionSee also: Body Cavity, Minor Survival Surgery, Substantial Impairment
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 certain types of medical care).See also: Children
an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: 1) recognized in the USPÐNF, 2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or 3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.
either a psychiatric disorder (e.g., psychosis, neurosis, personality, or behavior disorder), a developmental disorder (e.g., mental handicap), or a neurological disorder that affects cognitive or emotional functions to the extent that it results in an Impaired Decision-Making Ability.See also: Capacity, Cognitively Impaired, Guardian, Incapacitated, Incompetent
The probability and magnitude of harm or discomfort anticipated in the 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 VA studies the determination includes tangible or intangible risk. For DOD research the determination does not include the inherent occupational risks that certain subjects face in their everyday life.See also: Exempt Human Subjects Research, Expedited Review
an IRB determination when the research uses procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and whenever appropriate, the research uses procedures already being performed on the subjects for diagnostic or treatment purposes.
a modification to research which in the judgment of the reviewer does not fundamentally alter the judgments relied upon to make determinations on any of the criteria for IRB approval under 45CFR 46.111 does not adversely impact the overall risk-benefit relationship for the subjects of the research (based on new or modified risk information). For studies originally approved by expedited review, a minor change is a modification that does not change the study's eligibility for expedited review (considering risk and expedited review categories 1-9).See also: Amendment
does not expose a body cavity and causes little or no physical impairmentSee also: Major Survival Surgery
When an animal is in the state of dying, or at the point of death. Moribund animals may experience pain and distress during progression to a moribund condition.
research conducted at more than one location and under the jurisdiction of more than one IRB.
research conducted at more than one location and under the jurisdiction of only one IRB.
are newborns who are 30 days old or younger.
an application filed with the FDA to obtain approval to market a new drug.See also: FDA Regulated Research
an institution that does not hold an OHRP-approved Federalwide Assurance.See also: Assurance of Compliance, Assured Institution
research that meets the regulatory definition of human subjects research that does not qualify for exemption. Includes clinical trials, non-clinical trial research and research data or specimen repositories.See also: Exempt Human Subjects Research
research that does not involve "human subjects" as defined by the regulations.See also: Human Subject, Human Subjects Research
non-exempt human subjects research that does not meet the criteria to be considered a clinical trial (i.e., observational or repository).See also: Clinical Trial
Non-pharmaceutical grade agents refer to chemical compounds that have not been formulated for production of medicine. Agents obtained from chemical supply companies, novel compounds, and or agents prepared in a research laboratory are of reagent and not pharmaceutical grade.
Measures such as acclimation training, fluids, warmers, heating pads, or bedding that are used to minimize distress, discomfort, suffering or pain.
activity that does not meet the regulatory definition of research.See also: Research
All non-invasive procedures or invasive procedures limited to entering a preexisting orifice that does not involve cutting with a scalpel, scissors, biopsy forceps, punch biopsy, laser, cautery, direct tissue damage by cold (liquid nitrogen) or any comparable device or technique.
Any surgical intervention in which the animal will not recover from anesthesia (euthanized before waking).
research that has no likelihood of intent of producing a diagnostic, preventive, or therapeutic benefit to the current subjects, although it may benefit subjects with a similar condition in the future.See also: Clinical Trial, Non-Interventional Research
conducting research in a manner that disregards or violates applicable federal regulations, failure to follow the requirements and determinations of the IRB or IACUC (as applicable), or applicable institutional policies and procedures (in the case of VA research it includes noncompliance with the requirements of the VA Handbook as applicable).See also: Continuing Noncompliance, Serious Noncompliance
a device that does not meet the definition for a significant risk device.See also: Significant Risk Device
an infant, in the first 28 days after live birth, who cannot survive outside the womb.
In research federal regulations require, after delivery, there must be a determination as to whether the neonate is viable (viable means being able to survive (given the benefit of available medical therapy) to the point of independently maintaining heartbeat and respiration. Additionally, there are limitations on determining viability of neonates - individuals engaged in the research may not have any part in determining the viability of a neonate being considered for inclusion in a study. In addition, after delivery, nonviable neonate may not be involved in research unless there is scientific justification for their inclusion, legally effective informed consent of both parents (exceptions apply, see IRB Form U - Research Involving Pregnant Women, Human Fetuses And/Or Neonates) and all of the following additional conditions are met:
(1) Vital functions of the neonate will not be artificially maintained;
(2) The research will not terminate the heartbeat or respiration of the neonate;
(3) There will be no added risk to the neonate resulting from the research;
(4) The purpose of the research is the development of important biomedical knowledge that cannot be obtained by other means; and
(5) The legally effective informed consent of both parents of the neonate is obtained (waiver or alteration of consent is not allowed). However, there are some exceptions
research in which biomedical and/or health outcomes are assessed in pre-defined groups of individuals. Subjects in the study may receive diagnostic, therapeutic, or other interventions, but the investigator does not assign specific interventions to the subjects of the study.See also: Non-Interventional Research
1) Cohort: group of individuals, initially defined and composed, with common characteristics, who are examined or traced over a given time period 2)Case-control: group of individuals with specific characteristics compared to group(s) with different characteristics, but otherwise similar 3) Case-only: single group of individuals with specific characteristics 4) Case-crossover: characteristics of case immediately prior to disease onset (or hazard period) compared to characteristics of same case at a prior time (i.e., control period) 5) Ecologic or community studies: geographically defined populations, such as countries or regions within a country, compared on a variety of environmental and/or global measures not reducible to individual level characteristics 6) Family-based: studies conducted among family members, such as genetic studies within families or twin studies and studies of family environmentSee also: Observational Study, Observational Study Time Perspective
the temporal relationship of observation period to time of subject enrollment. Prospective: look forward using periodic observations collected predominantly following subject enrollment Retrospective: look back using observations collected predominantly prior to subject selection and enrollment Cross-sectional: observations or measurements made at a single point in time, usually at subject enrollmentSee also: Observational Study, Observational Study Model
designates research conducted at study sites that are not part of the UT Health San Antonio.
office responsible for implementing HHS regulations governing HHS funded research with human subjects. (OHRP)See also: Assurance of Compliance
office responsible for implementing HHS regulations governing use of animals in PHS funded projects. (OLAW)
abbreviation for the UT Health San Antonio Office of the Institutional Animal Care Program.
abbreviation for the UT Health San Antonio Office of the IRB.
monitoring or auditing a study while on the UT Health campus.See also: Remote Monitoring, Sponsor Monitoring
abbreviation for the VPR's Online Research Compliance Assistant application.
Organized Research Unit provides 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)
the agreement of parent(s) or guardian to the participation of their child or ward in research or clinical investigation and includes the elements of consent set forth in federal regulations and outlined in the informed consent template included in the IRB expedited and full review applications.See also: Children, Informed Consent
a physical location where research activities or protocol-directed procedures are performed.
Any active or inactive drug, biologic, reagent, etcetera, which is approved by the FDA for which a chemical purity standard has been written or established by any recognized pharmacopeia, which is a book or a compendia, such as the US Pharmacopeia (USP), the National Formulary (NF), the British Pharmacopoeia (BP), the Pharmacopoeia of the Council of Europe (EP). Note that both the USP and the NF have combined their standards into one compendia (http://www.usp.org/usp-nf).
includes both the theft or misappropriation of intellectual property and the substantial unattributed textual copying of another's work. Plagiarism is a form of research misconduct.
1. The theft or misappropriation of intellectual property includes the unauthorized use of ideas or unique methods obtained by a privileged communication, such as a grant or manuscript review.
2. Substantial unattributed textual copying of another's work means the unattributed verbatim or nearly verbatim copying of sentences and paragraphs which materially mislead the ordinary reader regarding the contributions of the author.
3. Plagiarism does not include authorship or credit disputes.See also: Fabrication, Fabrication, Falsification, Research Misconduct
a consented individual who undergoes minimal procedures or gives authorization to obtain additional health records prior to a complete screening activity. The information obtained in prescreening is used to determine if a subject meets the minimum requirements to proceed to be screened.See also: Subject Statuses
a pre-screened individual determined to be ineligible to proceed to screening.See also: Subject Statuses
encompasses the time from confirmation of implantation (through any of the presumptive signs of pregnancy, such as missed menses, or by a medically acceptable pregnancy test), until expulsion or extraction of the fetus.
individual with primary responsibility for the design and conduct of a project approved under the authority of the IRB or IACUC. Includes the intellectual conduct of the project, fiscal accountability, administrative aspects, and the project's adherence to relevant policies and regulations.
any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial or sentencing.
control over the extent, timing and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others.
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 that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).
Is for an animal procedure room but does not meet specifications for animal Housing Room.
1. Physical or Chemical restraint lasting more than 4 hours, OR
2. Diagnostic procedures such as laparoscopy or needle biopsies, OR
3. Surgery procedures, OR
4. Ocular blood collection in mice, OR
5. Terminal cardiac blood collection, OR
6. Ascites tumors for monoclonal antibody production, OR
7. Complete Freund's Adjuvant, OR
8. Tumor growth, OR
9. Research that requires continuation until clinical symptoms are evident or death occurs, OR
10. Ocular or skin irritancy testing, OR
11. Food or water deprivation beyond that necessary for ordinary pre-surgical preparation, OR
12. Application of noxious stimuli such as electrical shock if the animal cannot avoid/escape the stimuli and/or it is severe enough to cause injury or more than momentary pain or distress, OR
13. Tail snip if more than 5mm or if done after weaning (21 days old in rats or mice), OR
14. Toe clip if done after 12 days old.
assessments of the success of established programs in achieving objectives when the assessments are for the use of program managers, for example, a survey to determine if program beneficiaries are aware of the availability of program services or benefits. Not generally considered a research activity as long as the evaluation is designed to assess or improve the program or service rather than to generate knowledge about a disease or condition.See also: Non-Regulated Research
A PI report notifying the institution and the designated IRB or IACUC when specific urgent issues are identified.
Individually Identifiable Health Information transmitted by electronic media, maintained in electronic media, or transmitted or maintained in any other form or medium. PHI excludes education records covered by the Family Educational Rights and Privacy Act and employment records held by a covered entity in its role as employer.
step-by-step details of how a study will be conducted including objectives, design, procedures, measurements, management and analysis, as well as a discussion of relevant research ethics issues.
all procedures, therapies, interventions or interactions that are required by the protocol. Even procedures that are considered to be standard practice are still protocol directed if the protocol requires it.
Data and/or biospecimens that are accessible to anyone in the general public, without the need for special qualifications, permissions, or privileges. Examples include: data/biospecimens available for public purchase, searchable online, or available at a library.
Can data/biospecimens be publicly available if I have to register or sign an agreement to access the data/biospecimens? Yes, if the opportunity to register or sign an agreement is open to the general public, the data/biospecimens are still deemed publicly available.
activities particular to an institution's QA program, such as those activities protected from disclosure by the Department of Veterans Affairs as part of its confidential medical quality-assurance program or other equivalent programs. (e.g., see VHA Directives or equivalent university or institutional policy)See also: Non-Regulated Research
systematic, data-guided activities designed to bring about immediate, positive changes in the delivery of health care in particular settings. QI involves deliberate actions to improve care, guided by data reflecting the effects QI is generally not considered research Ð however, QI activities can be research if they are also intended to contribute to generalizable knowledge.See also: Non-Regulated Research
the minimal number of IRB or IACUC members who must be present at a convened meeting for valid transaction of business.
participant previously completed screening and either did not complete the screening process or was determined to be ineligible.See also: Subject Statuses
in exempt research, recorded refers to information (data) that is collected or documented during the process of a research investigation. The information may be written, typed, copied, audio or video recorded, etc.See also: Exempt Human Subjects Research
a pre-enrollment activity used to find potential subjects.See also: Subject Statuses
involves strategies for obtaining comparable levels of information from the use of fewer animals or for maximizing the information obtained from a given number of animals (without increasing the pain or distress) so that in the long run fewer animals are needed to acquire the same scientific information.See also: Refinement, Replacement
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.See also: Subject Statuses
refers to modifications of husbandry or experimental procedures to enhance animal well-being and minimize or eliminate pain and distress.See also: Reduction, Replacement
essential documents are those which individually and collectively permit evaluation of the conduct of a research study and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor, and monitor with the regulatory requirements of various federal, state and local agencies.
the agency, organization, company or person primarily responsible for initiating and overseeing the research and ensuring the study complies with federal regulations
payment for actual expenses
there is at least a reasonable possibility that the unexpected adverse event may have been caused by the procedures involved in the research. Possibly related should be considered more likely than not, e.g., > 50% chance that it is at least partially related should be the threshold since the alternative would not be considered a reasonable possibility)See also: Adverse Event
Indicates the institution that is relying on another organization's IRB or IACUC (reviewing IRB or IACUC)See also: External IRB, Reviewing IRB, sIRB
monitoring or auditing a study while not physically present on the UT Health campus.See also: Onsite Monitoring, Sponsor Monitoring
refers to methods that avoid using animals. Including: 1) Absolute replacement (i.e., replacing animals with inanimate systems such as computer programs); OR 2) Relative replacement (i.e., replacing animals such as vertebrates with animals that are lower on the phylogenic scale)See also: Reduction, Refinement
data management centers (data centers) and human specimen repositories (sometimes called registries, banks, or libraries) are used to store data and/or specimens for future use. When the use is for research purposes, the data centers/repositories must be approved by the Institutional Review Board (IRB). Human Specimen Repositories collect, store, and distribute human tissue/specimen materials for research purposes. Repository activities involve three components: (i) the collectors of tissue samples; (ii) the repository storage and data management center; and (iii) the recipient investigators. Human repository repositories may be combined with data management centers.See also: Collector
a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
The Belmont Report provides addition clarification:
“…the term "research' designates an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge (expressed, for example, in theories, principles, and statements of relationships). Research is usually described in a formal protocol that sets forth an objective and a set of procedures designed to reach that objective."
Activities which meet this definition constitute research, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities. Some research development or testing and evaluation may also meet this definition.See also: Clinical Investigation, Generalizable Knowledge
Fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. Research misconduct does not include honest error or differences of opinion.See also: Fabrication, Falsification, Plagiarism
a procedure or activity performed solely for the study.
physical (manual or mechanical) or chemical (anesthetic or tranquilizer not used in conjunction with surgery) means to limit some or all of an animals normal movement or behavior.
the research involves data or specimens that already exist in their entirety at the time of IRB submission.
or "designated IRB" indicates the IRB reviewing on behalf of relying institutions.See also: External IRB, Relying Institution, sIRB
a potential harm described in terms of probability (chance) and magnitude (severity).
Generally in research, risks of research that a reasonable person, in what the investigator knows or should know to be the subject’s position, would be likely to consider significant in deciding whether or not to participate in the research should be disclosed to the potential subject.
Risks may be physical, social, legal, economic or psychological in nature, and may relate to employability or insurability. In addition, risks may apply to the individual subject or may apply to a broader segment of the society
Risk is usually discussed in terms of two factors probability (chance) and magnitude (severity). In order to minimize the risk, the researcher and the IRB need to assess the chances the risk will occur and how severe that risk can be, then look at the mechanism or methods built into the research for decreasing both the chance and severity.
For example, risk that a metal object may become a projectile during an MRI procedure. The severity could be high, but if precautions are taken the probability is low.
Additionally in certain circumstances additional parameters of risk such as permanence and immediacy should be included in the description of risk in research. For example it may improve a potential subjects understanding of the risk and assist them in deciding whether or not to participate, if for some risks they were told whether the effect might be permanent rather than self limiting or at least treatable and for some risks the subject should be informed whether they should only expect this effect immediately or whether it might occur after the have left the care of the researcher in which case might they need emergency care.See also: Benefit
applicable to interventional study, indicates a pre-intervention step commonly involving a run-in or wash out of study interventions.
screened participant determined to be ineligible for enrollment because they do not meet the eligibility criteria, or other requirements for research participation.See also: Subject Statuses
individuals who are screened to determine eligibility.
a 'pre-enrollment' activity used to determine eligibility. Screening procedures are necessary solely for the purpose of determining eligibility.See also: Subject Statuses
any adverse event that: 1) results in death; OR 2) is life-threatening (places the subject at immediate risk of death from the event as it occurred); OR 3) results in inpatient hospitalization or prolongation of existing hospitalization; OR 4) results in a persistent or significant disability/incapacity; OR 5) results in a congenital anomaly/birth defect; OR 6) based upon appropriate medical judgment, may jeopardize the subject's health and may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.See also: Adverse Event
noncompliance that may: adversely affect subject safety or the safety of others; increase risks to subjects; violate the rights and welfare of participants (any of which may also be an unanticipated problem). Serious noncompliance may affect the subject's willingness to participate in research or may affect the integrity of the data (which may also be scientific misconduct). The unfounded classification of a serious adverse event as anticipated constitutes serious non-compliance.See also: Noncompliance
a clinical department, clinic , hospital or provider who has agreed to perform specific procedures outlined in the study plan (e.g., imaging by radiology or consults with specialists).
diseases or conditions causing major irreversible morbidity.See also: Emergency Use
a deficiency that in the judgment of the IACUC and the Institutional Official, is or may be a threat to the health or safety of the animals.
as a device that presents a potential for serious risk to the health, safety, or welfare of a subject and (1) is intended as an implant; or (2) is used in supporting or sustaining human life; or (3) is of substantial importance in diagnosing, curing, mitigating or treating disease, or otherwise prevents impairment of human health; or (4) otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.See also: IDE
The single IRB (sIRB) policy is a NIH policy that applies to most grants and contracts submitted to NIH on or after January 25, 2018 that involve multi-site non-exempt human subjects research. The policy requires the use of a single IRB to accomplish IRB review and approval for all domestic sites.See also: Institutional Review Board, Reviewing IRB
a sponsor visit to evaluate a performance site/investigator resources and capabilities to conduct a study in terms of site infrastructure, adequacy and availability of the site facilitiesSee also: Sponsor
A meeting requested by the sponsor of a newly approved/activated trial for the study team at the clinical site to review the specifics (e.g.: the science, design, procedures, CRF completion etc.) of the protocol in preparation to enroll the first subject.
Source documents are original documents, data, or records that are created during a clinical study, that relates to the medical treatment and the history of the participant, and from which study data are obtained. Source documents are one type of essential document that is required by GCP guidelines.
e.g., hospital records, clinic and office charts, laboratory notes, memoranda, subjects’ diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate and complete, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories, and at medico-technical departments involved in the clinical trial.
As determined by the IRB, whether a member of the study staff has a specialized skill or expertise in performing a high-risk research procedure. Removing or replacing someone designated as having a specialized skill from the study requires IRB approval.
are the agencies, institutions, companies, organizations, foundations, or individual grantors responsible for the initiation, management, or financing of a research study. The term sponsor is understood to include any intermediaries, such as contract research organizations or coordinating centers, acting as agents of the sponsor in carrying out the responsibilities above. All research falling under these types of agreements is considered sponsored research. In FDA regulated research, the Sponsor is the entity who takes responsibility for and initiates a clinical investigation. The sponsor can be any legal entity, including a company, an academic organization, or an individual. The intent of the sponsor's IND/IDE is to allow testing for marketing approval of the drug or device. These are generally considered commercial or corporate IND/IDEs.
Sponsors of clinical investigations involving human drugs, biological products, medical devices, and combinations thereof are required to provide oversight to ensure adequate protection of the rights, welfare, and safety of human subjects and the quality of the clinical trial data submitted to FDA. FDA’s regulations require sponsors to monitor the conduct and progress of their clinical investigations. The regulations are not specific about how sponsors are to conduct such monitoring and are therefore compatible with a range of approaches to monitoring that will vary depending on multiple factors. Monitoring activities include communication with the PI and study site staff; review of the study site’s processes, procedures, and records; and verification of the accuracy of data submitted to the sponsor.See also: Onsite Monitoring, Remote Monitoring
is an individual who both initiates and conducts a clinical investigation and under whose immediate direction the investigational drug/device is being administered, used or dispensed. For administrative reasons, only one individual should be designated as the sponsor. Usually, the intent of the sponsor-investigator IND/IDE is to gain scientific knowledge without seeking market approval for the drug or device. These are considered 'Investigator-Initiated' or sponsor-investigator IND/IDEs.See also: FDA Regulated Research, IDE, IND, Sponsor Monitoring, Sponsor-Investigator IND/IDE
There are three general categories: 1) new drug/device developed by the investigator, OR 2) new uses, new routes of administration, new dosages, or new patient populations for currently approved drugs, OR 3) new use of a significant risk device that has either been cleared under 510 (k) or approved under a Premarket Approval (PMA).
care or procedures that are routinely or typically provided absent a research study. (Also called generally accepted practice, routine or conventional care)See also: Standard Practice
care or procedures that are routinely or typically provided absent a research study. (Also called generally accepted practice, routine or conventional care)
study operations centers are designed to assist the study PI in meeting the oversight responsibility of the entire project.
any investigator who is not the Principal Investigator.
used to track the various states (milestones) in a subject's trajectory through a research study. The HSC's Clinical Trial Management System (CTMS) recognizes the following statuses for use in all types of clinical research (not just clinical trials):
of physical or physiologic Function: the circumstance where the animal is not expected to be normal after a reasonable postoperative recovery period. Examples include, but are not be limited to those procedures permanently and significantly affecting ambulation, physiology, the immune system, and mentation.
any change or request for additional information required by the IRB that is directly relevant to the determinations required to approve research 45 CFR 46.111.
any change or request for additional information required by the IRB that is directly relevant to the determinations required to approve research 45 CFR 46.111.
creation of a novel opening in the body or of a pre-existing orifice that involves cutting with a scalpel, scissors, biopsy forceps, punch biopsy, laser, electrocautery, or direct tissue damage by cold (liquid nitrogen) or any comparable device or technique.See also: Major Survival Surgery, Minor Survival Surgery
when Informed Consent is obtained from a Legally Authorized Representative (LAR) consent.See also: Legally Authorized Representative, Legally Effective Informed Consent
means that the animal recovers from anesthesia following a Surgical Procedure. See Surgery. In accordance with the AWARs and the Guide all survival surgeries require aseptic technique.See also: Surgery
a temporary cessation of some or all of the research activities by the IRB.See also: Termination of Research
use of a clear plan, system or method to conduct a detailed examination or inquiry for facts.See also: Research
any procedure in which the animal is under anesthesia and will be euthanized before waking.
a permanent cessation of all research activity by the IRB.See also: Suspension of Research
a general term that encompasses Drug, Device, food additives, etc. that are regulated by the FDA.See also: Device, Drug
research designed with the intent of producing a diagnostic, preventive, or therapeutic benefit.See also: Clinical Trial, Interventional Study
refers to healthcare providers (e.g., physicians, nurses, aides, technicians, and administrative assistants that are normally involved with the delivery of routine medical care.
FDA approved for treating rare conditions based on safety and probable benefit. IRB approval prior to non-emergency use is required.See also: Humanitarian Device Exemption, Humanitarian Use Device
serious adverse effect on health or safety; or any life-threatening problem; or death caused by, or associated with, a device, if: not previously identified in nature, severity, or degree of incidence in the investigational plan or application, or any other unanticipated serious problem associated with a Device that relates to the rights, safety, or welfare of subjects.See also: Unanticipated Problem Involving Risk to Subjects or Others
any incident, experience or outcome that meets all of the following criteria:
1) unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied (note: the unfounded classification of a serious adverse event as anticipated constitutes serious non-compliance);
2) related or probably related to participation in the research; and
3) suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.
a device that is used for a purpose or condition for which the device requires, but does not have, an approved application for premarket approval.See also: Investigational Devices
the offer of inducements excessive, unwarranted, inappropriate or improper reward or other overture in order to obtain compliance.
It also argues that “unjustifiable pressures” occur when “persons in positions of authority … urge a course of action for a subject.” This includes manipulating a prospective subject’s choice by utilizing the “influence of a close relative.” Lastly issues may be raised as potential undue influence when judgment may be compromised by financial incentives especially when the subject is not the recipient of the financial incentive. Undue influence needs to be distinguished from coercion for the purposes of UTHSCSA IRB applications of policy. Coercion is considered the use of a threat of harm or punishment to influence behavior; e.g., in general, payments do not constitute coercion per se. There are also less apparent examples of vulnerability to undue influence such as Institutional vulnerability and Deferential vulnerability to undue influence. Institutional is when an individual is subject to the formal authority of others which could influence the subject’s participation. Examples- prisoners, military personnel, students, employees. Deferential is similar to institutional but arises from informal relationships characterized by inequities in social status (gender, race, class) power or knowledge (doctor-patient relationship), or cognitive ability (elderly person defer to adult kids). Heightened concern that subject’s decision re: participation not truly voluntary. Deferential vulnerability can be very subtle- investigators must be especially sensitive to potential for subjects to believe refusing to participate will negative impact their future treatment. Investigators need to be sensitive to such deference and assess whether subject is truly exercising his/her autonomy and adjust the informed consent accordingly (a suggested addition to the usual consent process might include discussing participation in absence of the individual to whom the potential subject ordinarily defers-additional because the PI or investigator with the relationship may be the best person to discuss the study and answer questions and it would not be appropriate to bypass them all together). Deferential may be misconstrued to include therapeutic misconception but it is generally a separate concept though still requiring consideration in the consent process. Where potential subjects may be drawn to research because of lack of effective standard treatments and desire to find treatment they may be prone to misunderstand the risks and potential benefits and have unreasonable expectations about potential benefits. Pay special attention to ensuring potential benefits of participation are properly characterized. Where investigator is also treating physician, in addition to the issue of deference, there exists a higher risk of therapeutic misconception. Again you may want to consider having impartial third party obtain consent or finalize the consent process in the absence of the individual to whom the potential subject ordinarily defers.See also: Coercion, Voluntary
any adverse event, the nature, severity, or frequency of which is not consistent with either: (1) the known or foreseeable risk of adverse events associated with the procedures involved in the research that are described in (a) the protocol related documents, such as the IRB-approved research protocol, any applicable investigator brochure, and the current IRB-approved informed consent document, and (b) other relevant sources of information, such as product labeling and package inserts; or (2) the expected natural progression of any underlying disease, disorder, or condition of the subject(s) experiencing the adverse event and the subject's predisposing risk factor profile for the adverse eventSee also: Adverse Event
anonymous is an unidentified collection of human biological materials or data, or unlinked or anonymized, originate from identified materials or data but have been stripped by the source (not the researcher) of all identifiers or codes such that the ability to identify particular individuals via clinical or demographic information supplied with the sample, or information derived from the Research would be impossible for the investigator, the repository, or a third party.
abbreviation for the US Department of Agriculture
USDA regulations pertain to all vertebrates except the following: 1) Birds bred for use in research; 2) Rats of the genus Rattus bred for use in research; 3) Mice of the genus Mus bred for use in research; or 4) Horses not used for research purposes
is the clinical practice of the Long School of Medicine of UT Health San Antonio.
any research that involves any of the following:
1) sponsored by the VA
2) being conducted by or under the direction of any salaried or without compensation employee of the VA during official duty time or in connection with VA responsibilities
3) being conducted at a VA facility
4) recruiting subjects at the VA or using the VA records to identify or contact subjects for research
5) funded or managed by the VA or the Foundation for Advancing Veterans Health Research
pertains to the fetus, means being able, after either spontaneous or induced delivery, to survive (given the benefit of available medical therapy) to the point of independently maintaining heartbeat and respiration. Once a fetus is viable it is a premature infant.See also: Nonviable Neonates
ANIMAL: a violation of the standards promulgated by the AWA or assurances required by federal agencies.
HUMAN: a departure (generally intentional on the part of the investigator) from the approved study protocol, and occurs without prior IRB approval that:
1) has the potential to cause harm or increase the risk of harm to one or more research participants or
2) has the potential to damage the scientific integrity of the data collected for the study; or
3) impacts a subject's safety, rights, or welfare.
free of coercion, duress or undue inducement; used in research context to refer to a subject’s decision to participate (or to continue to participate) in a research activity.See also: Coercion, Undue Influence
applicable prior to participant reaching the active treatment or active observations phase, is an early end to all participation for an enrolled subject (even if the subject did not start the treatment).See also: Subject Statuses