Any experience or abnormal finding that has taken place during the course of a research project and was harmful to the subject participating in the research, or increased the risks of harm from the research, or had an unfavorable impact on the risk/benefit ratio; Any untoward or unfavorable…

A group or subgroup of participants in a clinical trial that receives specific interventions, or no intervention, according to the study protocol. This is decided before the trial begins.

An agreement by an individual not competent to give legally-valid informed consent (e.g., a child aged 7+ or cognitively-impaired person) to participate in research

The U.S. Congress commissioned the Belmont Report (1979) in response to public outrage over the Tuskegee syphilis study conducted by the U.S. Public Health Service. The report addresses the three ethical principles of respect for persons, beneficence, and justice.

https://www.hhs.gov/…

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.

A point of view or preference which prevents impartial judgment in the way in which a measurement, assessment, procedure, or analysis is carried out or reported.

Any therapeutic serum, toxin, anti-toxin, or analogous microbial product applicable to the prevention, treatment, or cure of diseases or injuries.

A printed, optical, or electronic (eCRF) document designed to capture all protocol-required information for a study.

A case report is one in which three or fewer records are accessed. Case reports do not meet the definition for human subjects research and do not require submissions to the IRB if the project meets the following criteria:

A study comparing persons with a given condition or disease (the cases) and persons without the condition or disease (the controls) with respect to antecedent factors.

Abbreviation for Computerized Axial Tomography, an X-ray technique for producing images of internal bodily structures through the assistance of a computer.

Centers for Disease Control and Prevention; an agency within the Public Health Service, Department of Health and Human Services.

A cell-line refers to a collection of a participant's white blood cells that are kept alive, usually stored in a freezer. Researchers are able to study these cells repeatedly for many years.

A document issued by NIH for certain types of research that provides additional protection of data from legal subpoena. The Certificate provides protection against compelled disclosure of identifying information or other identifying characteristics of a research participant enrolled in…

Persons who have not attained the legal age for consent to treatment or procedures involved in the research, as determined under the applicable law of the jurisdiction in which the research will be conducted.

Use of a drug or medical device other than the use of an approved drug or medical device in the course of medical practice, when data will be gathered, submitted to, or held for inspection by the FDA in support of an FDA marketing permit for a food, including a dietary supplement that bears a…

An individual that handles the administrative and day-to-day responsibilities of a clinical trial and acts as a liaison for the clinical site. This person may collect the data or review it before it is entered into a study database.

Any experiment that involves a test article and one or more human subjects and is subject to requirements for submission to the Food and Drug Administration. Clinical investigations must not be initiated unless that investigation has been reviewed and approved by an IRB. 

A research study in which one or more human subjects are prospectively assigned to one or more interventions interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes…

ClinicalTrials.gov is a Web-based resource that provides patients, their family members, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions. The Web site is…

The Code of Federal Regulations is an annual codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government.

The U.S. Department of Health and Human Services (HHS) issues and enforces rules…

Having either a psychiatric disorder (e.g., psychosis, neurosis, personality or behavior disorders, or dementia) or a developmental disorder (e.g., mental retardation) that affects cognitive or emotional functions to the extent that capacity for judgment and reasoning is significantly diminished…

A group of subjects initially identified as having one or more characteristics in common who are followed over time. In social science research, this term may refer to any group of persons who are born at about the same time and share common historical or cultural experiences.

The real or apparent interference of one person's interests with the interests of another person, where potential bias may occur due to prior or existing personal or professional relationships.  A conflict of interest occurs when individuals involved with the conduct, reporting, oversight,…

Commonly referred to as the "ICF" or "Informed Consent Form". These are the documents presented to a subject or parent/guardian prior to beginning a study. Most studies will have this document submitted with the proposal, unless requesting a Waiver. The IRB has provided a template on the web…

A pattern of repeated actions or omissions to act that suggests a future likelihood of reoccurrence and that indicates a deficiency in the ability or willingness to comply with Federal regulations or the policy, requirements, and determinations of the IRB governing human subject research.

The group of individuals in a clinical trial assigned to a comparison intervention.

A type of clinical trial in which observations made during the trial are compared to a standard (called the control). The control may be observations from a group of participants in the same trial or observations from outside the trial (for example, from an earlier trial, called a historical…

Control subjects (followed at some time in the past or for whom data are available through records) who are used for comparison with subjects being treated concurrently. The study is considered historically controlled when the present condition of subjects is compared with their own condition on…

A group organized to coordinate the planning and operational aspects of a multi-center clinical trial. CCs may also be referred to as Data Coordinating Centers (DCCs) or Data Management Centers (DMCs).

COPPA imposes certain requirements on operators of websites or online services directed to children under 13 years of age, and on operators of other websites or online services that have actual knowledge that they are collecting personal information online from a child under 13 years of age.…

Health care providers who conduct certain financial and administrative transactions electronically, such as billing and fund transfers; also, all health plans and health care clearinghouses (45 CFR 160.103). Covered Entities must comply with HIPAA regulations.

Several areas within the…

Describes a clinical trial in which groups of participants receive two or more interventions in a particular order. For example, a two-by-two crossover design involves two groups of participants. One group receives drug A during the initial phase of the trial, followed by drug B during a later…

Data and Safety Monitoring means the process to ensure and maintain the scientific integrity of human subject research and to protect the safety of human subjects, a system for appropriate oversight and monitoring to ensure the safety of participants and the validity of the data. The section of…

The processes of handling the data collected during a clinical trial from development of the study forms/CRFs through the database locking process and transmission to statistician for final analysis.

A Data Use Agreement (DUA) is a contractual document used for the transfer of data that has been developed, where the data is nonpublic or is otherwise subject to some restrictions on its use. Often this data is a necessary component of a research project and it may or may not be human subject…

Information that does not identify an individual and with respect to which there is no reasonable basis to believe that the information be used to identify an individual.  This includes that there is no means to re-identify individuals after the data have been de-identified (e.g., using a…

Giving subjects previously undisclosed information about the research project following completion of their participation in research. (Note that this usage, which occurs within the behavioral sciences, departs from standard English, in which debriefing is obtaining rather than imparting…

Deception is the intentional misleading of subjects or the withholding of full information about the nature of a research experiment or procedure. Misleading or omitted information might include the purpose of the research, the role of the researcher, or what procedures in the study are actually…

The World Medical Association adopted the Declaration of Helsinki (1964) as guidance for medical doctors undertaking biomedical research involving human subjects. The Declaration has been continuously revised. It addresses important issues including the principle of risk to benefit ratio in…

Individuals who are placed at special risk by virtue of their socioeconomic and/or educational background. As research participants, these individuals may be vulnerable to coercion or undue influence.

Indication that the clinical trial intervention produces a desired therapeutic effect on the disease or condition under investigation.

List of criteria guiding enrollment of participants into a study. The criteria describe both inclusionary and exclusionary factors, (e.g. inclusion criterion - participants must be between 55 and 85 years old; exclusion criterion – must not take drug X three months prior to the study).

Pertaining to that which relieves of a responsibility, obligation, or hardship; clearing from accusation or blame.

Review of proposed research by the IRB Chairperson or a designated voting member or group of voting members rather than by the entire IRB. Federal rules permit expedited review for certain kinds of research involving no more than minimal risk and for minor changes in approved research.

When a continuing review of the research does not occur prior to the end of the approval period specified by the IRB, IRB approval expires automatically. The study expires on the date specified on the approval letter and the informed consent document. No activities can occur on the expiration…

When an institution uses an external IRB, it remains responsible for the remaining Human Research Protection Program components. UIUC manages these responsibilities with a Facilitated Review application.  The IRB does not review the Facilitated Review application, because the external IRB…

A standing agreement on file with the Office for Human Research Protections that describes in detail the procedures it will use to protect the rights and welfare of the human subjects.

The Family Educational Rights and Privacy Act or FERPA provides certain rights for parents regarding their children’s education records. When a student reaches 18 years of age or attends an institution of postsecondary education at any age, the student becomes an “eligible student,” and all…

Once a study is completed, this form is submitted to close out the study.

An agency within the U.S. Department of Health and Human Services (DHHS) responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, nation’s food supply, cosmetics, and products that emit…

General Data Protection Regulation (GDPR) is a European data privacy law that took effect on May 25, 2018 intended to protect the privacy of individuals located inside the European Economic Area (EEA).

The European Economic Area consists of the following countries: Austria, Belgium,…

A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial participants are…

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. It also means an individual who is authorized to consent on behalf of a child to participate in research.

The first comprehensive Federal protection for the privacy of personal health information. The Privacy Rule regulates the way certain health care groups, organizations, or businesses, called covered entities under the Rule, handle the individually identifiable health information known as…

A healthy volunteer is a person with no known significant health problems who participates in clinical research to test a new drug, device, or intervention.

A living individual about whom an investigator conducting research obtains:

Intervention includes both physical procedures by which data are gathered and manipulations of the…

Literally, "in glass" or "test tube;" used to refer to processes that are carried out outside the living body, usually in the laboratory, as distinguished from in vivo.

Literally, "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 (in vitro).

A process by which a participant or legal guardian voluntarily confirms his or her willingness to participate in a particular research project, after having been informed of all aspects of the research that are relevant to the subject's decision to participate. Informed consent is documented by…

A document that describes the rights of a study participant and provides details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document.

An independent body constituted of medical, scientific, and nonscientific members whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of…

A procedure or treatment such as a drug, nutritional supplement, gene transfer, vaccine, behavior or device modification that is performed for clinical research purposes (45 CFR 46.102(f)). Interventions can also include noninvasive approaches such as surveys, education, and interviews.

A compilation of the clinical and non-clinical data on the investigational product(s) that is relevant to the study of the investigational product(s) in human subjects.

A person authorized either by statute or by court appointment to make decisions on behalf of another person. In human subject research, 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…

A study designed to follow subjects forward through time.

A set of procedures describing study conduct. A MOP is developed to facilitate consistency in protocol implementation and data collection across study participants and clinical sites.

A procedure in which the investigator administering the assessments and intervention as well as the participants in a clinical trial are kept unaware of the treatment assignment(s). Single blinding usually refers to the study participant(s) being unaware, and double blinding usually refers to…

According to the FDA, a device is: "An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

The manner in which a drug is acted upon (taken up, converted to other substances, and excreted) by various organs of the body.

Minimal risk means that 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 (45 CFR 46.102(i…

A federal agency within the Public Health Service, DHHS, comprising 21 institutes and centers. It is responsible for carrying out and supporting biomedical and behavioral research.

Member of an Institutional Review Board who has no ties to the parent institution, its staff, or faculty. 

Research that has no likelihood or 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.

The proposition, to be tested statistically, that the experimental intervention has "no effect," meaning that the treatment and control groups will not differ as a result of the intervention. Investigators usually hope that the data will demonstrate some effect from the intervention, thereby…

Modern human subjects protections begin with the Nuremberg Code. The Code (1949) was developed following the Nuremberg Military Tribunal as a standard by which to judge human experimentation conducted by the Nazis. It addresses many of the basic principles governing the ethical conduct of human…

A study where a researcher records or observes the observations or measurements without manipulating any variables. These studies show that there may be a relationship but not necessarily a cause and effect relationship. 

A federal government agency within the Department of Health and Human Services (DHHS) charged with the protection of human subjects participating in government funded research. It issues assurances and oversees compliance of regulatory guidelines by research institutions.

https://www.hhs…

The agreement of parent(s) or guardian to the participation of their child or ward in research [45 CFR 46.402(c)].

The process (in a living organism) of absorption, distribution, metabolism, and excretion of a drug or vaccine.

The scientific discipline that studies the action of drugs on living systems (animals or human beings).

A placebo is an inactive pill, liquid, powder, or other intervention that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the treatment's effectiveness.

A method of investigation in which an inactive substance/treatment (the…

The Protection of Pupil Rights Amendment, or PPRA, is a federal law that provides certain rights for parents of students regarding, among other things, student participation in surveys; the inspection of instructional material; certain physical exams; and the collection, disclosure, and use of…

The person who is responsible for the scientific and technical direction of the entire study (for example, for all sites of a multi-site study).

An individual involuntarily confined in a penal institution, including persons: (1) sentenced under a criminal or civil statue; (2) detained pending arraignment, trial, or sentencing; and (3) detained in other facilities (e.g., for drug detoxification or treatment of alcoholism) under statutes…

The person whose case serves as the stimulus for the study of other members of the family to identify the possible genetic factors involved in a given disease, condition, or characteristic.

Preventive or protective; a drug, vaccine, regimen, or device designed to prevent, or provide protection against, a given disease or disorder.

Studies designed to observe outcomes or events that occur subsequent to the identification of the group of subjects to be studied. Prospective studies need not involve manipulation or intervention but may be purely observational or involve only the collection of data.

A document that describes the objective(s), design, methodology, statistical consideration, and organization of a research project.

This public act was approved by the governor and signed into law on 6/22/2000. This bill requires that any human subject research conducted by the University of Illinois' medical school must provide consent in a language understandable to the participant. 

https://www.ilga.gov/…

These are activities designed to improve the quality of a process or assess its overall function. Such activities do not satisfy the definition of “research” under 45 CFR 46.102(d), which is “…a systematic investigation, including research development, testing and evaluation, designed to develop…

Materials that stop or attenuate radiation that is passed through the body, creating an outline on film of the organ(s) being examined. Contrast agents, sometimes called "dyes," do not contain radioisotopes. When such agents are used, exposure to radiation results only from the X-ray equipment…

The process of assigning clinical trial participants to treatment or control groups using an element of chance (e.g. like flipping a coin) to determine the assignments in order to reduce bias.

The plan that outlines how individuals will be recruited for the study and how the study will reach the recruitment goal.

Acronym for Roentgen Equivalent in Man; the unit of measurement for a dose of an ionizing radiation that produces the same biological effect as a unit of absorbed does (1 rad) of ordinary X-rays. One millirem is equal to 1/1000 of a rem.

A period in which the signs and symptoms of a disease are diminished or in abeyance. The term "remission" is used when one cannot say with confidence that the disease has been cured.

A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

A systematic investigation is an activity that is planned in advance and that uses data…

An ethical principle discussed in the Belmont Report requiring that individual autonomy be respected and persons with diminished autonomy be protected.

The plan that details the methods in which the study will use in order to retain study participation in the trial.

Research conducted by reviewing records from the past (e.g., birth and death certificates, medical records, school records, or employment records) or by obtaining information about past events elicited through interviews or surveys. Case control studies are an example of this type of research.…

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 possible harm may vary from minimal to significant. Federal regulations define only "minimal risk." 

An essential document that records all individuals who entered the screening process. The screening log demonstrates the investigator’s attempt to enroll a representative sample of participants.

A process designed to determine individual’s eligibility for participation in a clinical research study.

Secondary data is data collected by someone other than the user. Common sources of secondary data for social science include censuses, surveys, organizational records and data collected through qualitative methodologies or qualitative research. Primary data, by contrast, are collected by the…

Any adverse event that:

An act or omission to act that resulted in significant harm (physical, psychological, safety, or privacy) or significantly increased the possibility of harm to the rights and welfare of research participants.

A group of participants that receives a procedure or device that is made to be indistinguishable from the actual procedure or device being studied but does not contain active processes or components.

Original documents, data, and records (e.g., written assignments, surveys, hospital records, clinical and office charts, laboratory notes, memoranda, participant diaries, recorded data from automated instruments, x-rays, etc.) that are used in a research study.

An individual who both initiates and actually conducts - alone or with others - a clinical investigation. Corporations, agencies, or other institutions do not qualify as Sponsor-Investigators.

Detailed written instructions to achieve uniformity of the performance of a specific function across studies and patients at an individual site.

Established safety criteria that would either pause or halt a study due to reasons including but not limited to futility or risk(s) to the participants.

Separation of a study cohort into subgroups or strata according to specific characteristics such as age, gender, etc., so that factors which might affect the outcome of the study, can be taken into account.

An individual that handles the administrative and day-to-day responsibilities of a study and acts as a liaison for the site, if applicable. This person may collect the data or review it before it is entered into a study database.

Specimen collection banks, whether they are described as "banks" or not, are many and varied. They cover the spectrum from individual clinicians' research specimen collections, (often gathered with no specific project in mind) to institutional "Tissue Banks" (such as cancer center shared…

Certifies the authenticity of the translation of a translated Consent Document. The Certification form can be found on the OPRS website.

Unanticipated problems are defined as any incident, experience or outcome that occurs during the course of a study that meets all of the following criteria:

In some situations, the IRB can waive the requirement that research subjects sign an Authorization Form. To qualify for a Waiver of Authorization, the research use of the health information should not represent more than a minimal risk to privacy, and the researcher should indicate that the…

An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either:

(1) That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a…

Occasionally there are reasons to waive written consent or to alter the requirements of consent. Only the IRB can make the determination to waive some (written) or all (written and verbal) consent requirements.

In order to qualify for a Waiver of Consent, the following conditions should…

A ward means a child who is placed in the legal custody of the State or other agency, institution, or entity, consistent with applicable Federal, State, or local law. The term “ward of State” may be used interchangeably with “ward” in OPRS/IRB documents. For inclusion in a study, a number of…