a. Administrative Modification – Changes proposed to the IRB that are minor and non-substantive in nature and for which the IRB has delegated authority to IRB staff to conduct Administrative Review and approval, regardless of the study’s initial level of review or funding source. 

b. Adverse event - Any unfavorable or harmful occurrence to a human subject which occurs during the time that the subject is enrolled as a participant in the research, whether or not the occurrence is considered related to the subject’s participation in the research. This includes any abnormal medical sign (for example, an abnormal physical exam or laboratory finding), symptom, disease, or death, as well as adverse psychological events such as suicidal behavior, homicidal behavior, or increase in depression or anxiety symptoms.  Additionally, changes in life situations such as the arrest or runaway of a study participant, eviction or loss of home, or dropping out of school are also harmful occurrences that should be reported as adverse events whether or not they are related to participation in the research.

c. Advocate – An individual who has the background or experience to act in (and agrees to act in) the best interest of a potentially vulnerable subject for the duration of the subject’s participation in a research study. 

d. Benign Behavioral Intervention – A research intervention that is brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing.

e. Biospecimen - A quantity of tissue, blood, urine, or other human-derived material. A biospecimen can comprise subcellular structures, cells, tissue (e.g., bone, muscle, connective tissue, and skin), organs (e.g., liver, bladder, heart, and kidney), blood, gametes (sperm and ova), embryos, fetal tissue, and waste (urine, feces, sweat, hair and nail clippings, shed epithelial cells, and placenta).  Some are collected originally for clinical lab tests, some are removed during surgeries, and some are obtained specifically for research.

f. Broad Consent – A type of consent process that is intended to serve as a substitute for traditional informed consent in certain circumstances.  Broad consent allows subjects to agree to a wide range of future secondary research studies using their identifiable information or biospecimens.  With broad consent, researchers would not be required to obtain additional consent for each future use, so long as the activities are within the scope of the original broad consent.

g. Clinical Investigation (as defined by FDA) - Any experiment that involves an FDA regulated “test article” and one or more human subjects, and that either must meet the requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the act, or need not meet the requirements for prior submission to the Food and Drug Administration under these sections of the act, but the results of which are intended to be later submitted to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit. The term does not include experiments that must meet the provisions of part 58, regarding nonclinical laboratory studies. The FDA considers the terms research, clinical research, clinical study, study, and clinical investigation to be synonymous.

h. CLIA-Certified Laboratory - A laboratory that provides testing services for human specimens for the purposes of health assessment or diagnosis, prevention, or treatment of disease and is certified by the Center for Medicare Services (CMS) to meet federal regulatory quality standards for medical or clinical laboratory testing.

i. Coded Data – A dataset containing information about a living individual that has had the direct identifiers of the individual removed (e.g., name, SSN#, student #, etc.) and replaced with a code (e.g., 101, 102, 103, etc.); the research team typically keeps a separate file containing the list of subject code numbers and other identifiable information as a “Master List” so that the coded dataset can be re-linked to the subjects’ identities if needed using the subject code numbers. 

j. Conflict of Interest – An IRB member may not vote on a project, and is not counted towards a quorum, when s/he serves as a co-investigator or other member of the research team or when s/he or an immediate family member has a conflict of interest with a project being reviewed. Research Conflict of Interest (RCOI) is defined as a significant financial interest that could directly and significantly affect the design, conduct, or reporting of research. 

k. Continuing Noncompliance – A pattern of noncompliance (serious or non-serious) that results in multiple findings of noncompliance over time for similar protocol violations (either on the same protocol, or for the same investigator across multiple protocols) despite prior communications from the IRB attempting to address and correct the violation(s); continuing noncompliance could also result from repeated failures of the investigator to respond to or resolve previous allegations or findings of noncompliance.

l. De-identified Data – a dataset containing only information about living individual(s) that has all direct identifiers removed from the data in a manner that any member of the research team is not able to identify the individual(s) from whom the information was collected.  Links between the data and the individual about whom the data was recorded may still exist, but are not readily accessible, and will not be made available to the researcher(s) at UTA.  Note that studies utilizing a coding system with a “Master List” linking subject codes to identifiable information are not considered de-identified; instead, these datasets are considered “Coded Data.”

m. Device (as defined by the FDA) - 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. 1. recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them;

   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;

   3. or 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

n. Drug (as defined by the FDA) – Substances that are:

1. 1. recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and 

   2. intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and

   3. (other than food) intended to affect the structure or any function of the body; and

   4. intended for use as a component of a medicine, but are not a device or a component, part or accessory of a device.

j. Exempt Review – A level of IRB review in which study submissions are reviewed by IRB staff or one member of the IRB and granted a determination of exemption; applies to federally funded or FDA-regulated studies that are no more than minimal risk to participants and involve only procedures listed in one or more of the categories allowable for exemption at 45 CFR 46.101(b) or 21 CFR 56.104.

k. Expedited Review – A level of IRB review in which study submissions are reviewed and granted approval by at least one member of the IRB; applies to federally funded or FDA-regulated studies that are no more than minimal risk to participants and involve only procedures listed in one or more of the categories allowable for Expedited review per 45 CFR 46.110 and 21 CFR 56.110.

l. FDA – The Food and Drug Administration is a federal agency of the United States Department of Health and Human Services. The FDA is responsible for protecting and promoting health through the regulation and supervision of clinical trials, including new drugs and investigational new medical devices.

m. Full Board Review – A level of IRB review in which study submissions are reviewed and voted upon by IRB Members at a convened IRB meeting; required for federally funded or FDA-regulated studies that are not eligible for exempt or expedited review procedures, or federally funded or FDA-regulated studies where the procedures involved would pose greater than minimal risks to the participants.

n. Greater than Minimal Risk – Research activities that do not meet the definition of Minimal Risk.

o. Greater than Minimal Risk Review Category (GMR Review) – An internal “flex” review pathway for UTA IRB study submissions that are not federally funded or supported nor FDA regulated and pose greater than minimal risks to study subjects; to qualify for GMR Review, the study must comply with the principles of the Belmont Report and UTA IRB Operating Procedures, but not necessarily all aspects of 45 CFR 46.  GMR research may be reviewed by the IRB via consultation with IRB staff, by one or more IRB member(s), or by the full committee at an IRB meeting. 

p. HIPAA - The Health Information Portability and Accountability Act (HIPAA) enacted by Congress and signed into law in 1996.   The HIPAA Privacy Rule created national standards to protect individuals’ medical records and other personal health information from unauthorized disclosure.

q. HIPAA Covered Entity – Organizations which are required to follow the HIPAA Privacy Rule due to the kinds of medical information they collect and use during normal business operations. Covered entities are defined in the HIPAA rules as (1) health plans, (2) health care clearinghouses, and (3) health care providers who electronically transmit any health information in connection with transactions for which HHS has adopted standards.  UT Arlington is not a HIPAA Covered Entity.

r. Human Subject – A living individual about whom an investigator (whether professional or student) conducting research obtains a) data through intervention or interaction with the individual, or b) identifiable private information, even if no intervention or interaction with the researcher occurs.

s. Identifiable Biospecimen - A biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen (such as through the use of codes which link to identifying information).

t. Identifiable Data – A dataset containing any information that would allow someone (including members of the research team) to be able to directly or indirectly identify the person from whom the information was collected; a dataset in which the identity of the subject can be or may be readily ascertained by someone or is associated with the information. Coded datasets are considered identifiable data when members of the research team have access to the “Master List” which links subject codes to other subject identifiers, i.e. names, email addresses, student IDs. 

u. Institution – Any public or private entity, organization, business, or agency (including federal, state, or other agencies). 

v. Institutional Official (IO) - An officer of an institution who is legally authorized to speak for and legally commit the institution within legal agreements, including the adherence to the requirements of the federal regulations regarding the involvement of human subjects in biomedical and behavioral research.

w. Interaction – A method of collecting research data about a human subject that includes communication and/or interpersonal contact between the investigator and the subject.

x. Intervention - A method of collecting research data about a human subject for research purposes that could include both physical procedures by which data are gathered (for example, venipuncture), and/or manipulations of the subject or the subject's environment for research purposes.

y. Legally Authorized Representative (LAR) - An individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research. If there is no applicable law addressing this issue, legally authorized representative means an individual recognized by institutional policy as acceptable for providing consent in the nonresearch context on behalf of the prospective subject to the subject’s participation in the procedure(s) involved in the research.

z. Major Modifications – Changes proposed to an IRB-approved research project that would or could increase the likelihood and/or severity of the risks posed to the study subjects.

aa. Minimal Risk – A term meaning that the probability and magnitude of harm or discomfort anticipated to the subject in the research are not greater in and of themselves than those ordinarily encountered in the subject’s daily life or during the performance of routine physical or psychological examinations or tests; federally funded studies that involve greater than minimal risks to the participants are reviewed at the full board level.

bb. Minimal Risk Review Category (MR Review) – An internal “flex” review pathway for UTA IRB study submissions that are not federally funded or supported nor FDA regulated and pose no more than minimal risks to study subjects; to qualify for minimal risk review, the study must comply with the principles of the Belmont Report and UTA IRB Operating Procedures, but not necessarily all aspects of 45 CFR 46.  IRB Staff is designated with responsibility and authority to review and approve MR research, with consultation from the IRB when deemed necessary.

cc. Minor Modifications – Changes proposed to an IRB-approved research project that pose no additional risks to participants beyond those previously identified at the time of the original protocol approval.  A subset of minor modifications are eligible for Administrative Review by IRB staff. 

dd. Monitoring Entity - The group or person(s) responsible for overseeing the safety of all subjects enrolled in a study in accordance with the approved protocol; this may be a Data Safety Monitoring Board (DSMB), a Data Monitoring Committee (DMC), a coordinating or statistical center, an experienced colleague not affiliated with the study, or a study sponsor.

ee. Noncompliance – A finding of failure on the part of the PI or any member of the study team to follow: i. federal regulations, state laws, or institutional policies relevant to human subjects research; or ii. the requirements and determinations issued by the reviewing IRB as stated in the approved IRB protocol.  Information regarding noncompliance in research studies involving human subjects may come to the attention of the IRB through several pathways.  These include internal monitoring of research projects, information contained in new applications, continuing reviews, adverse experience reports, and reports from collaborators, employees, subjects, or others.

ff. OHRP – The Office for Human Research Protections (OHRP) provides leadership in the protection of the rights, welfare, and wellbeing of subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS). OHRP helps ensure this by providing clarification and guidance, developing educational programs and materials, maintaining regulatory oversight, and providing advice on ethical and regulatory issues in biomedical and social-behavioral research.

gg. Protected Health Information (PHI) – Information transmitted or maintained in any form (i.e., by electronic means, on paper, or through oral communication) that: (1) was collected or maintained by a HIPAA Covered Entity or Business Associate and 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 his or her past, present, or future payment for health care; and (2) identifies (or may reasonably identify) the individual.  PHI is protected by HIPAA laws.

hh. Protected Individual Information - Any personally identifiable information (other than PHI) that may cause substantive harm to subjects if there was a breach of confidentiality, such as social security numbers; financial information such as credit card numbers or bank account numbers; school grades; employment performance records; or information about illegal behaviors or criminal activity.

ii. Principal Investigator (PI) – The person who directs a research project or program and is ultimately responsible for the design, conduct, and reporting of the research. The PI is responsible for the protection of human subjects and the ethical conduct of research in compliance with federal regulations and University policies and procedures.

jj. Private Identifiable Information - Includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, as well as information which has been provided by an individual for specific purposes and which the individual can reasonably expect will not be made public (i.e., medical records or student records).  Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

kk. Protocol Violation – A divergence from the approved IRB protocol by the PI and/or research team without the prior IRB approval of a study modification request. Upon reported allegations or discovery of a potential protocol violation, the IRB and/or IRB staff will follow IRB procedures for investigating potential noncompliance included in this SOP, and will issue a finding of noncompliance if evidence indicates a violation has occurred. 

ll. Quorum – The required amount of members to be present at a convened IRB meeting in order for a vote to be effective per the regulations; a majority of voting members of an IRB (i.e., 50% of the IRB members on the IRB roster plus one), including at least one member whose primary expertise is in a nonscientific area.

mm. Reliance – An option for IRB approval of collaborative research projects where a single institution’s IRB can serve as the designated “IRB of Record” for all (or some) of the study sites engaged in the research project.  Reliance must be sufficiently documented between the IRBs of both the Reviewing and Relying institutions to be effective; this documentation may be through a standing institutional reciprocity agreement or an individual IRB Authorization Agreement as appropriate for each specific study and collaborating institution.

nn. Repository – A central location where data or human biological materials are organized, labeled, and stored with the specific intent of future research use.

oo. Research - A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research even if they are a component of another non-research activity (e.g., instruction, community service, program evaluation, quality improvement, demonstration).

pp. Risk – The probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study. Both the probability and magnitude of risks may vary from minimal to significant.

qq. Secondary Research – Re-use of identifiable information or biospecimens for research purposes that were or will be collected for some other primary / initial purpose or activity (whether research or non-research). 

rr. Serious Adverse Event (SAE) – Any adverse experience in a research participant that results in any of the following outcomes: death; a life-threatening adverse experience; inpatient hospitalization or prolongation of existing hospitalization; a persistent or significant disability/incapacity; a congenital anomaly/birth defect; required intervention to prevent permanent impairment or damage; suicide attempts; or other serious medical events.

ss. Serious Noncompliance - Noncompliance with federal regulations or institutional policies and procedures that, in the judgment of the reviewing IRB, affects the rights and welfare of subjects; may cause a significant risk to enrolled subjects or others; or affects the integrity of the study. 

tt. Unanticipated Problems (UPs) - Any incident, experience, or outcome that happens during a study and meets all of the following criteria:

1. 1. Is 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;

   2. Is related or possibly related to participation in the research (meaning there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved 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.

uu. Unexpected Adverse Event (UAE) – Any adverse experience or suspected adverse reaction that is not listed in the protocol, consent form, or other item included in the IRB application, such as the investigator brochure or package insert; or is not listed in the study materials at the specificity or severity that has been observed; or is otherwise not consistent with the risk information described in the protocol or informed consent document.