Glossary

Term Definition
Administrative Hold A voluntary action by an investigator, institutional official, or sponsor to temporarily or permanently stop some or all research activities. The administrative hold does not apply to interruptions of research related to concerns regarding the safety, rights or welfare of human research subjects or others. During administrative hold, the research remains subject to continuing review and requirements for reporting non-compliance and unanticipated problems involving risks to subjects or others. Administrative holds are not considered suspensions or terminations, and do not meet reporting requirements to OHRP, FDA and other federal agencies.
Adverse Event An untoward physical or psychological occurrence in a human subject participating in research. The event may be any unfavorable outcome, including abnormal laboratory result, symptom, disease or injury.
Assent A child's affirmative agreement to participate in research. The child’s failure to object, absent affirmative agreement, should not be considered assent.
Authorization of PHI An individual's written permission to allow a covered entity to use or disclose specified PHI for a particular purpose. Except as otherwise permitted by the Rule, a covered entity may not use or disclose PHI for research purposes without a valid Authorization.
Autonomy Personal capacity to consider alternatives, make choices, and act without undue influence or interference of others.
Beneficence An ethical principle discussed in the Belmont Report that entails an obligation to protect persons from harm. The principle of beneficence can be expressed in two general rules: (1) do not harm; and (2) protect from harm by maximizing possible benefits and minimizing possible risks of harm.
Biologic A biological or related product derived from living sources (e.g., humans, animals, microorganisms) and regulated by the FDA, including blood, vaccines, allergenics, tissues and cellular and gene therapies. Studies of unlicensed biologics are generally regulated according to the IND regulations. FDA regulations related to the general use and licensing of biologics are found in 21 CFR 600 and 601.
Cadaver The body of a deceased person.
Child / Children / Minor The federal research regulations define children as individuals who have not attained the legal age for consent to treatments or procedures involved in the research, under the State or local law of the jurisdiction in which the research will be conducted. In Illinois, individuals under the age of 18 are considered minors with certain exceptions.
Clinical Investigation Any experiment in which a drug (or biologic or device) is administered or dispensed to, or used involving, one or more human subjects. In this context, experiment refers to any use of a drug except for the use of a marketed drug in the course of medical practice. (21 CFR 312.3(b))
Clinical Trial A research study in which one or more human 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.
Co-Investigator Individuals who serve as key project personnel, but without the oversight responsibility of a Principal Investigator.
Confidentiality Refers to the investigators agreement with the subject on how a subject’s data will be handled, managed, and disseminated.
Continuing Non-compliance Non-compliance (serious or non-serious) that has been previously reported, or a pattern of ongoing activities that indicate a lack of understanding of or willingness to comply with the human subjects protection requirements that may affect research participants or the validity of the research and suggest the potential for future non-compliance without intervention.
Covered Entity Health plan, a health care clearinghouse, or a health care provider transmitting health information in electronic form in connection with a transaction subject to the HIPAA regulations.
Data Decryption Decryption is the process of converting encrypted data back into its original form, so the data can be usable and understood.
Data Encryption Encryption is the conversion of data into a form, through use of an algorithm, which renders electronic data, unusable, unreadable, or indecipherable by unauthorized persons.
Data Use Agreement Agreement into which the covered entity enters with the intended recipient of a limited data set that establishes the ways in which the information in the limited data set may be used and how it will be protected.
De-Identified Health Information Health information that does not identify an individual, and there is no reasonable basis to believe that the information can be used to identify an individual, is considered de-identified. In accordance with the HIPAA Privacy Rule, health information can be de-identified by two means: 1. Statistical Method. An independent, qualified statistician: a. Determines that the risk of re-identification of the data, alone or in combination with other data, is very small; and b. Documents the methods and results by which the health information is de-identified, and the expert makes his/her determination of risk. 2. Removal of All Identifiers (Safe Harbor Method). The removal of all 18 HIPAA elements from the health information that could be used to identify the individual or the individual’s relatives, employers, or household members. The de-identified health information may include a code (re-identification code) that will permit the information to be re-identified, if necessary, provided that; the key to such a code is not accessible to the researcher requesting the use or disclosure of the de-identified health information; that the code was not derived from or related to information about the individual or cannot be used to identify individuals; and the covered entity does not use or disclose the code for any other purpose, and does not disclose the mechanism for re-identification.
Dead fetus A fetus that exhibits neither heartbeat, spontaneous respiratory activity, spontaneous movement of voluntary muscles, nor pulsation of the umbilical cord.
Delivery Complete separation of the fetus from the woman by expulsion or extraction or any other means.
Device An instrument, apparatus, machine or similar article that is used for the diagnosis, mitigation, cure, prevention or treatment of disease and does not work through chemical action or metabolism within the body.
Designated Record Set Group of records maintained by or for a covered entity that includes: (1) medical and billing records about individuals maintained by or for a covered health care provider; (2) enrollment, payment, claims adjudication, and case or medical management record systems maintained by or for a health plan; or (3) used, in whole or in part, by or for the covered entity to make decisions about individuals. A record is any item, collection, or grouping of information that includes PHI and is maintained, collected, used, or disseminated by or for a covered entity.
Disclosure of PHI Release, transfer, provision of access to, or divulging in any other manner of PHI outside the entity holding the information.
Double-blind design A study design in which neither the investigators nor the subjects know the treatment group assignments of individual subjects.
Drug A product that is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or intended to affect the structure or function of the body and achieves its intended effect through chemical action or metabolism within or on the body.
Embryo 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).
Engaged / Engagement 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 (1) intervene or interact with living individuals for research purposes; and/or (2) obtain individually identifiable information from living individuals for research purposes; and/or (3) the site receives direct federal funding for research purposes.
ePHI Electronic Protected Health Information (PHI)
Equitable Fair or just; used in the context of selection of subjects to indicate that the benefits and burdens of research are fairly distributed.
Exculpatory Clearing or tending to clear from alleged fault or guilt. Statements of informed consent may not include exculpatory language that would justify, excuse, or clear an investigator from alleged fault or guilt (in the case of an adverse event), or through which the subject waives their legal rights [45 CFR 46.116].
Experimental subjects (DOD) The DoD defines “Research Involving a Human Being as an Experimental Subject” as an activity, for research purposes, where there is an intervention or interaction with a living individual for the primary purpose of obtaining data regarding the effect of the intervention or interaction. This definition does not include activities that are not considered research involving human subjects and activities that meet the exemption criteria at 32 CFR 219.104(d).
External Event or Problem Events occurring at non-UIC sites, i.e., where UIC IRB has no oversight responsibilities.
External IRB Any non-UIC IRB that performs a review of UIC research. This can include a commercial IRB (e.g., WIRB); IRBs affiliated with other hospitals, academic institutions, or organizations; and national center IRBs (e.g., National Cancer Institute Central IRB).
Family Educational Rights and Privacy Act (FERPA) A federal law designed to protect the privacy of students' educational records, to establish the right of students to inspect and review their educational records, and to provide guidelines for the correction of inaccurate or misleading data through informal and formal hearings. The law does this by governing the release and access to student education records maintained by an educational institution. FERPA applies when researchers obtain student records or personal education information from an education program as defined as any program principally engaged in the provision of education, including, but not limited to, early childhood education, elementary and secondary education, postsecondary education, special education, job training, career and technical education, and adult education. (20 U.S.C. § 1232g; 34 CFR Part 99) The UIC Office of the Registrar is responsible for oversight of student educational records and compliance with FERPA at UIC. Guidance and procedures governing student records at UIC is available at http://registrar.uic.edu/campus_policies/records_policy.html and releasing information pertaining to students at http://registrar.uic.edu/student_records/record_confidentiality.html.
Federal Wide Assurance (FWA) An agreement between DHHS and UIC that UIC will review and approve federally funded research involving human subjects in accordance with the ethical principles outlined in The Belmont Report and the DHHS regulations [45 CFR 46]. UIC's FWA # is #00000083.
Fetal Material The placenta, amniotic fluid, fetal membranes, and umbilical cord.
Fetus The product of conception from the time of implantation until delivery. If the delivered or expelled fetus is viable, it is designated an infant [45 CFR 46.203(c)]. The term "fetus" generally refers to later phases of development; the term "embryo" is usually used for earlier phases of development.
Foster Child In Illinois, a foster child is a ward of the state since the Illinois Department of Children and Family Services, an Illinois state agency, holds guardianship of the person for foster children. (Juvenile Court Act of 1987, 705 ILCS 405; Children and Family Services Act, 20 ILCS 505).
Generalizable knowledge The extent to which research findings and conclusions from a study conducted on a sample population can be applied to the population at large (i.e., extending the results beyond a single individual or an internal unit).
Greater Risk of Harm Means the research causes harm (including physical, psychological, economic, legal or social harm) to subjects or others (e.g., family members, co-workers, study staff) or places them at a greater risk of harm than was previously known or recognized.
Guardian An individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care. In Illinois, the term Guardian “means a court appointed guardian of the person who serves as a representative of a minor or as a representative of a person under legal disability.” In Illinois, a variety of guardianship appointments exist and the investigator should take care to document that the guardian’s representation of the ward is within the scope of their authority: limited guardianship, plenary guardianship, guardian of the person, guardian of the estate, and temporary guardianship. (Health Care Surrogate Act, 755 ILCS 40; Juvenile Court Act of 1987, 705 ILCS 405/1-2).
Guardianship of the Person of a Minor In Illinois, the duty and authority to act in the best interests of the minor, subject to residual parental rights and responsibilities, to make important decisions in matters having permanent effect on the life and development of the minor and to be concerned with their general welfare. It is includes but is not necessarily limited to . . . the authority to consent to major medical, psychiatric, and surgical treatment. (Juvenile Court Act of 1987, 705 ILCS 405/1-2). Please contact OPRS for guidance in temporary custody situations or for children who are placed by court under the guardianship of a probation officer, as these are complex situations that may require the advice of University Counsel.
Health Information Any 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.
Human Protections Administrator (HPA) The primary contact person for human subject protection issues, including the investigation and reporting of non-compliance matters, and plays a key role in ensuring that UIC fulfills its responsibilities under its FWA. At UIC, the HPA is the Director of the Office for the Protection of Research Subjects (OPRS).
Human Subject A living individual about whom an investigator (whether professional or student) conducting research (1) obtains data or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the data or biospecimens, or (2) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. [45 CFR 46.102(e)(1)]
Humanitarian Use Device (HUD) A medical device that is intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 8,000 individuals in the United States per year.
Hybrid Entity A single legal entity with business activities that include HIPAA covered (health care) and noncovered functions. For hybrid entities, HIPAA generally applies only to its designated covered (health care) components. The UIC is a hybrid entity. The list of covered components can be found at: https://hipaa.uillinois.edu/health-care-components/
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. [45 CFR 46.102(e)(6)]
Identifiable private information Private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information. [45 CFR 46.102(e)(5)]
Individually Identifiable Health Information Subset of health 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.
Institutional Official (IO) The individual who is legally authorized to act for the institution and, on behalf of the institution, obligates the institution to the Terms of the Federalwide Assurance (FWA). At UIC, the Vice Chancellor for Research is the IO.
Interaction Communication or interpersonal contact between investigator and subject. [45 CFR 46.102(e)(3)]
Internal / Local Event or Problem Events or problems occurring at UIC or other sites where the UIC IRB has oversight responsibility for the research and UIC IRB is the IRB of record.
Intervention Includes both physical procedures by which data or biospecimens are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes. [45 CFR 46.102(e)(2)]
Investigational Device Medical device that is the subject of a clinical study designed to evaluate the effectiveness or safety of the device, or a clinical evaluation of certain modifications or new intended uses of a legally marketed device. Clinical investigations that involve FDA regulated devices are subject to the requirements of 21 CFR 812.
Investigational New Drug Refers to an unapproved drug or biologic (or approved drug or biologic for an unapproved indication) used in an FDA-regulated clinical investigation. The term also includes biological products used in vitro for diagnostic purposes. Clinical investigations that involve FDA regulated drugs are subject to the requirements of 21 CFR 312.
Investigator Any person responsible for the design, conduct, or reporting of the research. In accordance with UIC HSPP policy, this includes, but is not limited to, the Principal Investigator, Faculty Sponsor, co-investigators, or other key research personnel. An investigator may be a faculty, staff, fellow, student, trainee, administrator, unpaid personnel (including volunteers), or other individual who engages the University in research involving human subjects pursuant to the review and approval of the IRB; or is otherwise identified as involved in research by a Principal Investigator, Unit Executive Officers, or other University administrative officer responsible for research activities.
IRB of Record The IRB of record (or reviewing IRB) is the IRB that assumes responsibilities for another institution or independent investigator for a specific study, group of studies, or for all research conducted by the institution/investigator. This relationship must be documented in advance by a reliance agreement.
Justice An ethical principle discussed in the Belmont Report requiring fairness in distribution of burdens and benefits; often expressed in terms of treating persons of similar circumstances or characteristics similarly.
Key Research Personnel Includes all persons who will have a significant role in the design or conduct of the research, and includes at a minimum all Principal Investigators and Co-Investigators, and any individuals who are individually named on a grant or contract application, who are listed on an FDA form 1572 (for the conduct of the research at UIC), who are named as contact persons in the informed consent documents or recruitment materials for research, and persons who are, or who provide supervision of the persons who are, obtaining informed consent to participate in research. Additionally, any individuals (including student researchers and coordinators) who are involved with the research by handling identifiable data or protected health information or are using the research information/data set as part of their own research should be included as research personnel on a protocol application.
Legally Authorized Representative (LAR) DHHS and the FDA define a legally authorized representative as “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.” (46.102(i); 21 CFR 50.3).
Limited Data Set PHI that excludes 16 categories of direct identifiers and may be used or disclosed, for purposes of research, public health, or health care operations, with a data use agreement and without obtaining either an individual's Authorization or a waiver or an alteration of Authorization.
Major Protocol Violations Violations that cause harm to subjects or others, place them at increased risk of harm, impact the scientific integrity of the research, compromise the human subject protection program, have the potential to recur or represent possible serious or continuing non-compliance. Major protocol violations Major protocol violations may represent an unanticipated problem (particularly when unintentional) and/or potential serious non-compliance and require prompt reporting.
Minimal Risk The probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons. Note: This definition of minimal risk differs from that in 45 CFR 46 Subpart A by replacing “harm or discomfort” with “physical or psychological harm” and using “healthy person” as the reference point for the medical, dental or psychological examinations.
Minimal Risk (DOD) When determining the risk level for DoD-supported research, the definition of minimal risk as “…ordinarily encountered in daily life or during the performance of routine physical or physiological examinations or tests” shall not be interpreted to include the inherent risks certain categories of human subjects face in their everyday life. For example, the risks imposed in research involving human subjects focused on a special population should not be evaluated against the inherent risks encountered in their work environment (e.g., emergency responder, pilot, soldier in a combat zone) or having a medical condition (e.g., frequent medical tests or constant pain).
Minimum Necessary Standard (in regards to PHI) Least information reasonably necessary to accomplish the intended purpose of the use, disclosure, or request of PHI. A covered entity that is using or disclosing PHI for research without Authorization must make reasonable efforts to limit PHI to the minimum necessary. A covered entity may rely on documentation of IRB approval as establishing that the request for PHI for the research meets the minimum necessary requirements.
Minor Protocol Violations Protocol violations that do not meet the definition of major protocol violations.
Non-compliance Conducting research involving human subjects in a manner that intentionally or unintentionally fails to comply with federal or state regulations, VA policies for VA research overseen by CHAIRb, UIC HSPP policies, or the requirements or determinations of the IRB. Examples include, but are not limited to, initiating research prior to IRB approval, implementing changes in the IRB-approved protocol without prior IRB approval, using inadequate procedures for informed consent, failing to meet education and training requirements and lapses in IRB approval.
Nonviable neonate A neonate after delivery that, although living, is not viable.
Personal Information As defined by the IL Personal Information Protection Act (PIPA – 815 ILCS 530/5), an individual’s first name or first initial and last name in combination with any one or more of the following data elements when either the name or the data elements are not encrypted or redacted: (1) social security number; (2) driver’s license number or State identification card number; or (3) account number or credit or debit card number, or an account number or credit card number in combination with any required security code, access code, or password that would permit access to an individual’s financial account. “Personal information” does not include publicly available information that is lawfully made available to the general public from federal, State, or local government records.
Personal Informed Protection Act (PIPA) The PIPA is an Illinois State Law that creates specific requirements for public universities and other data collectors to notify individuals when their personal information, such as their social security number, may have been improperly accessed.
Personally Identifiable Information (PII) Any information about an individual that could, potentially identify that person, such as a name, street address, credit card number, email address, telephone number or social security number. A subset of PII is PHI.
Pregnancy The period of time from implantation until delivery. A woman is assumed to be pregnant if she exhibits any of the pertinent presumptive signs of pregnancy, such as missed menses, until the results of a pregnancy test are negative or until delivery.
Privacy Refers to an individual and their desire to control the access that others have to their person.
Private Information 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 which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). [45 CFR 46.102(e)(4)]
Protected Health Information (PHI) Individually identifiable health information (including the individually identifable health information of non-U.S. citizens) transmitted or maintained in any form or medium (including oral, written, or electronic) that: • identifies or could be used to identify an individual: • is created or received by a healthcare provider, health plan, employer, or healthcare clearinghouse; and • relates to the past, present, or future physical or mental health or condition of an individual; the provision of healthcare to an individual; or the past, present, or future payment for the provision of healthcare to an individual.
Protection of Pupil Rights Amendment (PPRA) A federal law that affords certain rights to parents of minor students with regard to surveys that ask questions of a personal nature. The No Child Left Behind Act of 2001 contains a major amendment to PPRA that gives parents more rights with regard to the surveying of minor students, the collection of information from students for marketing purposes, and certain non-emergency medical examinations. (a.k.a., “Student Rights in Research, Experimental Programs, and Testing”) (20 U.S.C. § 1232h; 34 CFR Part 98)
Protocol Violation Any deviations, whether accidental, unintentional or intentional, from the IRB-approved protocol that are implemented prior to IRB approval.
Related or Possibly Related An event or problem is more likely than not to have been caused by the research because the event or problem may reasonable be regarded as caused by, or probably caused by, the research.
Research A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities deemed not to be research are specified in the UIC HSPP policy Determination Whether an Activity Represents Human Subjects Research at UIC.
Research (DoD) The DoD defines "research" as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
Respect for persons An ethical principle discussed in the Belmont Report requiring that individual autonomy be respected and that persons with diminished autonomy be protected.
Risk A risk may reflect potential physical, psychological, social, or economic harm
Sensitive Information Information that, if disclosed or modified without authorization, would have serious adverse effect on the operations, assets, or reputation of the University, or the University’s obligations concerning information privacy. Sensitive Data includes information that is covered by FERPA, Non-Disclosure Agreements (NDAs), and other intellectual property are, as a minimum, in this class. In the research setting, sensitive information also includes, but is not limited to individually identifiable information involving: • AIDS, sexually transmitted diseases, or alcohol or substance abuse or treatment • Illegal conduct or arrest record • Student education records • Sexual attitudes, preferences, or practices • Psychological or mental health information • Disclosure of information outside of research that could reasonably cause discrimination or stigmatization, or result in damage to subjects' financial well-being, employability, or reputation.
Serious Adverse Event An event is an untoward occurrence in human research that results in death, life-threatening injury, inpatient hospitalization or prolongation of hospitalization, persistent or significant disability, or a congenital anomaly or birth defect. Events not meeting the above criteria but requiring medical, surgical, behavioral, social, or other intervention to prevent one or more of these outcomes are also considered serious adverse events.
Serious Non-compliance Non-compliance that results in either substantive harm (or genuine risk of substantive harm) to the safety, rights or welfare of human subjects, research staff or others, substantively compromises the effectiveness of the HSPP or substantively impacts the integrity of the research
Serious Problem Problem that involves substantive harm, or a genuine risk of substantive harm, to the safety, rights, or welfare of research subjects, research staff, or others; or substantively compromises the effectiveness of a facility’s human research protection or human research oversight programs.
Systematic investigation A project that is planned in advance and that uses data collection and analysis to answer a specific question, testing a specific hypothesis, or developing a theory.
Unanticipated The specificity, severity or frequency of the event is new and not expected based on (a) information contained in the protocol, investigator’s brochure, informed consent document, drug or device product information or other research materials; and (b) the characteristics of the subjects, including underlying diseases, behaviors, or traits.
Unanticipated Adverse Device Effect Any serious adverse effect on health or safety or any life-threatening problem or death caused by or associated with a device used during human subjects research if that effect, problem, or death was 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.
Unanticipated Problems Involving Risks to Subjects or Others A problem or event that is unexpected, given the nature of the research procedures and the subject population being studied; related or possibly related to participation in research and suggests that the research places subjects or others at a greater risk of harm or discomfort related to the research than was previously known or recognized.
Unsecured PHI Protected health information that is not rendered unusable, unreadable, or indecipherable to unauthorized individuals through the use of technology or methodology specifically involving the encryption of data that are at rest (i.e. residing in databases) and/or data in motion (i.e. wireless transmission).
Use of PHI The sharing, employment, application, utilization, examination, or analysis of PHI within the entity or health care component (for hybrid entities) that maintains such information.
Viable As it pertains to the neonate, means being able, after delivery, to survive (given the benefit of available medical therapy) to the point of independently maintaining heartbeat and respiration.
Voluntary Free of coercion, duress, or undue inducement. Used in the research context to refer to a subject's decision to participate (or to continue to participate) in a research activity.
Ward Any child who is placed in the legal custody of the state or other agency, institution, or entity, consistent with the applicable federal, state, and local laws and regulations. In Illinois, a ward of the state includes but is not limited to a child placed by court under the guardianship of the Illinois Department of Children and Family Services. In Illinois, children placed in foster care are wards of the state. (Juvenile Court Act of 1987, 705 ILCS 405/ 2-7).