Adjuvant Therapy – Therapy provided to enhance the effect of a primary therapy; auxiliary therapy.
Adverse Event – An undesirable, unintended and not necessarily unexpected result of therapy or other intervention (e.g., a headache following a spinal tap or intestinal bleeding associated with aspirin therapy).
Affidavit of Accuracy – a document signed by a qualified translator in which the translator who performed or verified the translation affirms that the entire document has been translated, that nothing has been omitted or added, and that the translation is true and correct. A qualified translator is an officer or employee of an official translation bureau or agency or a professor or instructor who is teaching the translated language in an accredited college or university in the United States. The type of course being taught must be included in the Affidavit of Accuracy, which must be on official school stationery and notarized.
Assent - Agreement by an individual not competent to give legally valid informed consent (e.g., a child or cognitively impaired person) to participate in research.
Anonymity-Pertains to the information that an individual has disclosed in a study with the expectation that the information has no identifiers linked to the participant and therefore cannot in any way be traced to the participant. "Anonymity" and "confidentiality" do not have the same meaning and are not interchangeable.
Assurance – A formal written, binding commitment that is submitted to a federal agency in which an institution promises to comply with applicable regulations governing research with human subjects and stipulates the procedures through which compliance will be achieved.
Authorized Institutional Official - An officer of an institution with the authority to speak for and legally commit the institution to adherence to the requirements of the federal regulations regarding the involvement of human subjects in biomedical and behavioral research.
Autonomy – Personal capacity to consider alternatives, make choices, and act without undue influence or interference of others.
Belmont Report - A statement of basic ethical principles governing research involving human subjects issued by the National Commission for the Protection of Human Subjects in 1978.
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.
Benefit - A valued or desired outcome; an advantage.
Biologic - Any therapeutic serum, toxin, anti-toxin, or analogous microbial product applicable to the prevention, treatment, or cure of diseases or injuries.
Certificate of Confidentiality-a legal document that federal agencies issue to researchers to protect the privacy and welfare of subjects by preventing the release of identifiable and sensitive information about subjects who are participating in a research project.
Chair – Chair, Co-Chair, or Vice-Chair, as designated on IRB roster submitted to OHRP, unless otherwise indicated.
Child – In Virginia, all research individuals less than 18 years of age unless the individual is legally emancipated, as these are the individuals who under Virginia law meet the federal definition of a child.
Clinical investigation - any experiment that involves a test article and one or more human subjects and that either is subject to requirements for prior submission to the Food and Drug Administration under section 505(i), 507(d), or 520(g) of the act, or is not subject to 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 submitted later 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 are subject to the provisions of part 58 of this chapter, regarding nonclinical laboratory studies.
Clinical Trial - A controlled study involving human subjects, designed to evaluate prospectively the safety and effectiveness of new drugs or devices or of behavioral interventions.
Coercion-Pertaining to unacceptable participant recruitment methods which involve duress, undue inducement or indirect pressure. One example of an environment conducive to coercion involves the recruitment of employees by their employer for human participant research.
Cognitively Impaired -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. Others, including persons under the influence of or dependent on drugs or alcohol, those suffering from degenerative diseases affecting the brain, terminally ill subjects, and persons with severely disabling physical handicaps, may also be compromised in their ability to make decisions in their best interests.
Cohort - 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.
Compensation - Payment or medical care provided to subjects injured in research; does not refer to payment (remuneration) for participation in research.
Competence -Technically, a legal term, used to denote capacity to act on 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: Incompetence, Incapacity.)
Confidentiality -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 without permission in ways that are inconsistent with the understanding of the original disclosure.
Conflict of Interest – an IRB member may not vote on a project, and is not counted towards a quorum, when s/he or an immediate family member has a conflict of interest with a project being reviewed, defined as:
- Serving as a co-investigator or other member of the research team; or
- Receiving payments in excess of $10,000 including salary, consulting fees, royalty or licensing payments from intellectual property, honoraria and/or gifts from the study sponsor over the past 12 months or anticipated for the next 12 months (excluding salary and other payments for services from the University of Virginia); or
- Having equity interest worth more than $10,000 or more than 5% of the business entity as determined by reference to publicly listed prices (excluding mutual funds); or
- Having any equity interest if the value cannot be determined by reference to publicly listed prices (e.g., start-up companies); or
- Holding a position as director, officer, partner, trustee, employee, or any other position of management; or
- Holding patent rights or royalties from such rights whose value may be affected by the outcome of the research, including royalties under any royalty-sharing agreements involving the University of Virginia.
Continuation-Initial approvals for projects are given for up to one year from the date of IRB review. Projects lasting longer than a year require submission of a Protocol Status Form for approval to continue. Projects extending beyond year three must be resubmitted using full protocol templates.
Continuing non-compliance - A pattern of non-compliance that, in the judgment of the IRB Chair or convened IRB, indicates a lack of understanding of the regulations or institutional requirements that may affect the rights and welfare of participants, would have been foreseen as compromising the scientific integrity of a study such that important conclusions could no longer be reached, suggests a likelihood that non-compliance will continue without intervention, or frequent instances of minor non-compliance. Continuing non-compliance also includes failure to respond to a request to resolve an episode of noncompliance.
Contract - An agreement; as used here, an agreement that a specific research activity will be performed at the request, and under the direction, of the agency providing the funds. Research performed under contract is more closely controlled by the agency than research performed under a grant.
Contraindicated - Disadvantageous, perhaps dangerous; a treatment that should not be used in certain individuals or conditions due to risks (e.g., a drug may be contraindicated for pregnant women and persons with high blood pressure).
Control (Subjects) or Controls – subject(s) used for comparison who are not given a treatment under study or who do not have a given condition, background, or risk factor that is the object of study. Control conditions may be concurrent (occurring more or less simultaneously with the condition under study) or historical (preceding the condition under study). When the present condition of subjects is compared with their own condition on a prior regimen or treatment, the study is considered historically controlled.
Cross-over Design - A type of clinical trial in which each subject experiences, at different times, both the experimental and control therapy. For example, half of the subjects might be randomly assigned first to the control group and then to the experimental intervention, while the other half would have the sequence reversed.
Data and Safety Monitoring Board – board of scientists, physicians, statisticians, and others that collects and analyzes data during the course of a clinical trial to monitor for adverse effects and other trends (such as an indication that one treatment is significantly better than another, particularly when one arm of the trial involves a placebo control) that would warrant modification or termination of the trial or notification of subjects about new information that might affect their willingness to continue in the trial.
Debriefing – 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 information.)
Deception - in research means that the subject/respondent, at the time of the data collection, is not fully informed of the nature and purpose of the research in which she/he is involved so as to prevent potentially biased reporting of data/information.
Declaration of Helsinki – A code of ethics for clinical research approved by the World Medical Association in 1964 and widely adopted by medical associations in various countries. It was revised in 1975,1989, 1996, 2000 and 2002.
De-Identified Health Information - De-identified health information neither identifies nor provides a reasonable basis to identify an individual. There are two ways to de-identify information; either: 1) a formal determination by a qualified statistician; or 2) the removal of specified identifiers of the individual and of the individual’s relatives, household members, and employers is required, and is adequate only if the covered entity has no actual knowledge that the remaining information could be used to identify the individual.
Descriptive Study - Any study that is not truly experimental (e.g., quasi-experimental studies, correlational studies, record reviews, case histories, and observational studies).
Diagnostic (Procedure) -Tests used to identify a disorder or disease in a living person.
Double-masked Design - A study design in which neither the investigators nor the subjects know the treatment group assignments of individual subjects. Sometimes referred to as "double-blind."
Drug - Any chemical compound that may be used on or administered to humans as an aid in the diagnosis, treatment, cure, mitigation, or prevention of disease or other abnormal conditions.
Emancipated Child - A legal status conferred upon persons who have not yet attained the age of legal competency as defined by state law (for such purposes as consenting to medical care), but who are entitled to treatment as if they had by virtue of assuming adult responsibilities such as being self-supporting and not living at home, marriage, or procreation. A legal procedure whereby children become legally responsible for themselves and their parents are no longer responsible financially or otherwise. In Virginia, a child is considered as emancipated when;
- he/she becomes self supporting,
- joins the armed forces,
- is released from the control and supervision of his or her parents or guardian by the courts, or
- has a valid marriage.
Pregnancy does not emancipate a female unless other conditions are met. For example, moving out of the parents' or guardian’s house and into an apartment, setting up housekeeping with a partner, and having a baby can be emancipating, because the totality of the circumstances shows an intent to be free of the parents' custody, control, and support. However, the emancipation status will still be determined by the courts and is generally controlled by the contention that the female is free from the supervision and control of her parents or guardian and she has become self supporting, not that she is pregnant.
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).
Emergency use -the use of an FDA-regulated test article on a human subject in a life-threatening situation in which no standard acceptable treatment is available, and in which there is not sufficient time to obtain IRB approval.
Equitable - Fair or just; used in the context of selection of subjects to indicate that the benefits and burdens of research are fairly distributed.
Ethnographic Research - Ethnography is the study of people and their culture. Ethnographic research, also called fieldwork, involves observation of and interaction with the persons or group being studied in the group's own environment, often for long periods of time.
Existing Data – Data that existed prior to the initiation of a research project.
Expedited Review -Review of proposed research by the IRB chair 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.
Experimental - Term often used to denote a therapy (drug, device, procedure) that is unproven or not yet scientifically validated with respect to safety and efficacy. A procedure may be considered "experimental" without necessarily being part of a formal study (research) to evaluate its usefulness.
False Negative – when a test wrongly shows an effect or condition to be absent (e.g. that a woman is not pregnant when, in fact, she is)
False Positive – when a test wrongly shows an effect or condition to be present (e.g. that a woman is pregnant when, in fact, she is not)
Family member - means any one of the following legally competent persons: Spouse; parents; children (including adopted children); brothers and sisters; and any individual related by blood or affinity whose close association with the subject is the equivalent of a family relationship.
Federal-Wide Assurance (FWA) —An agreement between a federally funded institution and OHRP that stipulates method(s) by which the organization will protect research participants. (66 Fed. Reg. 19139, 19141 (April 13, 2001)).
FDA – Food and Drug Administration, an agency of the federal government established by Congress in 1912 and presently part of the Department of Health and Human Services.
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.
Fieldwork - Behavioral, social, or anthropological research involving the study of persons or groups in their own environment and without manipulation for research purposes (distinguished from laboratory or controlled settings).
510(K) Device – a medical device that is considered substantially equivalent to a device that was or is being legally marketed. A sponsor planning to market such a device must submit notification to the FDA 90 days in advance of placing the device on the market. If the FDA concurs with the sponsor, the device may then be marketed.
Full-Board Review - Review of proposed research at a convened meeting at which a majority of the membership of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. For the research to be approved, it must receive the approval of a majority of those members present at the meeting.
Gatekeeper – An individual or organization that controls access to research records, documents or specimens.
Gene Therapy - Human gene transfer is the process of transferring genetic material (DNA or RNA) into a person. At present, human gene transfer is experimental and is being studied to see whether it could treat certain health problems by compensating for defective genes, producing a potentially therapeutic substance, or triggering the immune system to fight disease. Human gene transfer may help improve genetic disorders, particularly those conditions that result from inborn errors in a single gene (for example, sickle cell anemia, hemophilia, and cystic fibrosis). It may also hold promise for diseases with more complex origins, like cancer and heart disease. Gene transfer is also being studied as a possible treatment for certain infectious diseases, such as AIDS. This type of experimentation is sometimes called “gene therapy” research.
Genetic Screening - Tests to identify persons who have an inherited predisposition to a certain phenotype or who are at risk of producing offspring with inherited diseases or disorders.
Genotype – The genetic constitution of an individual.
Good Clinical Practice (GCP) — Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial participants are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible. (International Code of Harmonization for Good Clinical Practice (ICH GCP)).
Grant – financial support provided for research study designed and proposed by the principal investigator. The granting agency exercises no direct control over the conduct of approved research supported by a grant.
Guardian -An individual who is authorized under applicable state or local law to give permission on behalf of a child to general medical care.
Health Science Research (HSR) - name of the IRB at the University of Virginia which approves biomedical research
HIPAA – Health Insurance Portability and Accountability Act of 1996. HIPAA governs the use and disclosure of protected health information (PHI) that is created or received by a covered entity that relates to:
- the physical or mental health of an individual (living or deceased)
- the provision of health care
- the payment for health care
- identifies the individual or reasonably may be used to identify the individual
Gives individuals the following rights:
- right to request restrictions on use or disclosure of their PHI
- right to access medical records (including research records)
- right to amend medical records
- right to an accounting of disclosure of their PHI
- right to request alternate confidential communications
- right to lodge complaint with covered entity and / or the Department for Health and Human Services
- Covered Entity must designate a Privacy Official
- Covered Entity must develop policies and procedures that are HIPAA compliant
- Covered Entity must provide privacy training to the workforce
- Covered Entity must implement administrative, technical and physical safeguards to protect the privacy of PHI
- Covered Entity must develop sanctions for violations of the HIPAA Privacy Rule
- Covered Entity must meet the documentation requirements
Historical Controls – 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 prior regiment or treatment.
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. Individuals whose physiologic or behavioral characteristics and responses are the object of study in a research project.
Human subject (as defined by the FDA) - means an individual who is or becomes a participant in research, either as a recipient of the test article as a control. A subject may be either a healthy human or a subject. This definition applies to all research involving drugs or devices.
Humanitarian Device Exemption (HDE) - A Humanitarian Device Exemption (HDE) is an application that is similar to a pre-market approval (PMA) application, but exempt from the effectiveness requirements of a PMA. An approved HDE authorizes marketing of a Humanitarian Use Device (HUD).
Humanitarian Use Device (HUD) - A device that is intended to benefit subjects in the treatment and diagnosis of diseases or conditions that affect or is manifested in fewer than 4,000 individuals in the United States per year.
Identifiable personal information - information relating to a reasonably identifiable person who has a reasonable expectation of privacy, including information about personal characteristics such as culture, age, religion and social status, as well as their life experience and educational, medical or employment histories.
Independent Variables – the conditions of an experiment that are systematically manipulated by the investigator.
Informed Consent - 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. In giving informed consent, subjects may not waive or appear to waive any of their legal rights, or release or appear to release the investigator, the sponsor, the institution or agents thereof from liability for negligence.
Institutional Review Board (IRB) -any board, committee, or other group formally designated by an institution to review, to approve the initiation of, and to conduct periodic review of, biomedical or behavioral/social science research involving human subjects. The primary purpose of such review is to assure the protection of the rights and welfare of the human subjects.
Interaction - includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.
Intervention - includes communication or inter-personal contact between investigator and subject.
Investigational Device Exemption (IDE) - Exemptions from certain regulations found in the Medical Device Amendments that allow shipment of unapproved devices for use in clinical investigations
Investigational New Drug (IND) or Device - A drug or device permitted by FDA to be tested in humans but not yet determined to be safe and effective for a particular use in the general population and not yet licensed for marketing.
Investigator - An individual who actually conducts a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to or used involving, a subject, or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team. IRB Member (Member) – An individual appointed by the Senior Vice President for Research or designee to serve on the IRB.
IRB approval - the determination of the IRB that the research study has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and Federal requirements.
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 Personnel – Participants in a research team who contribute in a substantive way to the scientific development or execution of a project, including the principal investigator
Legally Authorized Representative - 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.
Longitudinal Study - A study designed to follow subjects forward through time.
Major modifications – Modifications to a research project and/or consent documents that present additional risk to subjects such as dosage escalation, additional procedures or tests, significant increases in time commitment by subject, etc. Substantive protocol revisions also are considered major modifications.
Major Violation - A violation that may impact subject safety, affect the integrity of study data and/or affect subject’s willingness to participate in the study.
Medical Device - A diagnostic or therapeutic article that does not achieve any of its principal intended purpose through chemical action within or on the body. Such devices include diagnostic test kits, crutches, electrodes, pacemakers, arterial grafts, intraocular lenses, and orthopedic pins or other orthopedic equipment.
Mentally Disabled – See Cognitively impaired.
Minimal risk – 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.
Minor (in reference to a person) – In Virginia, means any person who has not reached the age of eighteen (18). In the Virginia Revised Statutes, the definition of a “minor” and a “child” are identical.
Minor - Lesser in seriousness or danger
Minor modifications – Modifications to a research project and/or consent documents that pose no additional risk to subjects such as changes in title, co-investigator(s), funding sources; addition or modification of procedures that fall into one of the categories eligible for expedited review; or modifications that maintain similar or increased safeguards to protect the subject.
Minor Violation -A violation that does not affect subject safety, compromise the integrity of study data and/or affect subject’s willingness to participate in the study.
Modification-A change made to the previously approved protocol or consent form.
Monitoring - The act of overseeing the progress of a research study to ensure that the rights and wellbeing of participants are protected, that the data are accurate, complete and verifiable, and that the conduct of the research is in compliance with the protocol, with applicable regulatory requirements and with standards of the field.
New Drug Application (NDA) - Request for FDA approval to market a new drug.
Non-affiliated Member - Member of an Institutional Review Board who has no ties to the parent institution, its staff, or faculty. This individual is usually from the local community (e.g., minister, business person, attorney, teacher, homemaker).
Non-compliance - Any action or activity associated with the conduct or oversight of research involving human subjects that fails to comply with federal regulations or institutional policies governing such research. Non-compliance actions may range from minor to serious, be unintentional or willful, and may occur once or several times. The degree of non-compliance is evaluated on a case-by-case basis and will take into account such considerations as to what degree subjects were harmed or placed at an increased risk and willfulness of the non-compliance. Examples include, but are not limited to:
- Failure to obtain IRB approval;
- Inadequate or non-existent procedures for the informed consent process;
- Inadequate supervision;
- Failure to follow recommendations made by the IRB;
- Failure to report adverse events or protocol changes; and
- Failure to provide ongoing progress reports.
Non-significant Risk (NSR) - An NSR device investigation is one that does not meet the definition for a significant risk study. NSR device studies, however, should not be confused with the concept of "minimal risk," a term utilized in the IRB regulations to identify certain studies that may be approved through an "expedited review" procedure.
Normal Volunteers - Volunteer subjects used to study normal physiology and behavior or who do not have the condition under study in a particular protocol, used as comparisons with subjects who do have the condition. "Normal" may not mean normal in all respects. For example, subjects with broken legs (if not on medication that will affect the results) may serve as normal volunteers in studies of metabolism, cognitive development, and the like. Similarly, subjects with heart disease but without diabetes may be the "normals" in a study of diabetes complicated by heart disease.
Null Hypothesis - 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 allowing the investigator to reject the null hypothesis.
Nuremberg Code - A code of research ethics developed during the trials of Nazi war criminals following World War II and widely adopted as a standard during the 1950s and 1960s for protecting human subjects.
Office of Human Research Protections (OHRP) – The office within the Department of Human and Human Services responsible for implementing DHHS regulations governing research involving human subjects.
Office of the Vice President for Research and Graduate Studies (VPRGS) — A system that includes all structural units, policies, and activities critical to protecting individuals studied in research and that is managed in accordance with these standards and with applicable federal, state and local laws. Some components of the HRPP may be external to the organization seeking accreditation, but the essential components of an HRPP should be identifiable in all cases.
Open Design - An experimental design in which both the investigator(s) and the subjects know the treatment group(s) to which subjects are assigned.
Oral consent-Written text describing what will be told to subjects when oral consent is necessary.
Paternalism - Making decisions for others against or apart from their wishes with the intent of doing them good.
Pharmacology – the scientific discipline that studies the action of drugs on living systems (animals or human beings)
Phase 1, 2, 3, 4 Drug Trials - Different stages of testing drugs in humans, from first application in humans (Phase 1) through limited and broad clinical tests (Phase 3), to postmarketing studies (Phase 4).
Phenotype - The physical manifestation of a gene function.
PHS - Public Health Service. Part of the U.S. Department of Health and Human Services, it includes FDA, NIH, CDC, SAMHSA, and HRSA.
Placebo - A chemically inert substance given in the guise of medicine for its psychologically suggestive effect; used in controlled clinical trials to determine whether improvement and side effects may reflect imagination or anticipation rather than actual power of a drug.
Preclinical Investigations – laboratory and animal studies designed to test the mechanisms, safety, and efficacy of an intervention prior to its applications to humans.
Premarket Approval – process of scientific and regulatory review by the FDA to ensure the safety and effectiveness of Class III devices.
Principal Investigator(PI) - A qualified person who directs a research project or program, may write the protocol, and oversees the scientific, technical and day-to-day management of the research.
Prisoner -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 or commitment procedures providing such alternatives to criminal prosecution or incarceration in a penal institution
Privacy - Control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others.
Private 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, 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). 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.
Prophylactic – preventive or protective; a drug, vaccine, regimen, or device designed to prevent, or provide protection against, a given disease or disorder.
Prospective Studies – 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.
Protected Health Information (PHI) – Individually identifiable health information including demographic data, that relates to:
- the individual’s past, present or future physical or mental health or condition,
- the provision of health care to the individual, or
- the past, present, or future payment for the provision of health care to the individual,
- and that identifies the individual or for which there is a reasonable basis to believe can be used to identify the individual. Individually identifiable health information includes many common identifiers (e.g., name, address, birth date, Social Security Number).
Protocol - The formal design or plan of an experiment or research activity; specifically, the plan submitted to an IRB for review and to an agency for research support. The protocol includes a description of the research design or methodology to be employed, the eligibility requirements for prospective subjects and controls, the treatment regimen(s), and the proposed methods of analysis that will be performed on the collected data.
Protocol Exception - Any temporary protocol deviation that is approved by the IRB prior to its initiation,
e.g., enrollment of a subject who does meet the eligibility criteria.
Note: Any permanent change to the protocol constitutes an amendment that must be submitted to the
IRB for approval prior to initiation.
Protocol Violation - Any protocol deviation that is not approved by the IRB prior to its initiation or implementation.
Quality Improvement (QI) - Periodic examination of organizational activities, policies, procedures and performance to identify best practices and target areas in need of improvement; includes implementation of corrective actions or policy changes where needed.
Quorum – A majority of voting members of an IRB, including at least one member whose primary expertise is in a nonscientific area.
Radioactive Drug - Any substance defined as a drug in §201(b)(1) of the Federal Food, Drug and Cosmetic Act that exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons [21 CFR 310.3(n)]. Included are any nonradioactive reagent kit or nuclide generator that is intended to be used in the preparation of a radioactive drug and "radioactive biological products," as defined in 21 CFR 600.3(ee). Drugs such as carbon-containing compounds or potassium-containing salts containing trace quantities of naturally occurring radionuclides are not considered radioactive drugs.
Radiopharmaceuticals – drugs that may be labeled or tagged with a radioisotope. These materials are largely physiological or subpharmacological in action, and, in many cases, function much like materials found in the body. The principal risk associated with these materials is the consequent radiation exposure to the body or to specific organ systems when they are injected into the body.
Randomization - Assignment of subjects to different treatments, interventions, or conditions according to chance rather than systematically (e.g., as dictated by the standard or usual response to their condition, history, or prognosis, or according to demographic characteristics). Random assignment of subjects to conditions is an essential element of experimental research because it makes more likely the probability that differences observed between subject groups are the result of the experimental intervention.
Recombinant DNA Technology - "The ability to chop up DNA, the stuff of which genes are made, and move the pieces, [which] permits the direct examination of the human genome," and the identification of the genetic components of a wide variety of disorders. Recombinant DNA technology is also used to develop diagnostic screens and tests, as well as drugs and biologics for treating diseases with genetic components.
Remission - 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.
Remuneration-Payment for participation in research.
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 a larger non-research activity (e.g., instruction, demonstration).
Retrospective Studies - 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.
Risk – the probability of harm or injury (physical, psychological, social, legal, or economic) occurring as a result of participation in a research study. Both the probability and magnitude may vary from minimal to significant.
Sequestration – segregating, holding separate.
Serious adverse experience (SAE) – Any adverse experience associated with the use of the drug/device that results in any of the following outcomes: death, a life-threatening adverse experience, insubject hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered a serious adverse experience when, based upon appropriate medical judgment, they may jeopardize the subject or subject and may require medical or surgical intervention to prevent one of the outcomes listed above.
Serious Non-compliance - An action or omission in the conduct or oversight of research involving human subjects that affects the rights and welfare of participants, increases risks to participants, decreases potential benefits or compromises the integrity or validity of the research. Examples of serious noncompliance include, but are not limited to:
- Conducting non-exempt research without IRB approval;
- Enrollment of subjects that fail to meet the inclusion or exclusion criteria of the protocol, that in the opinion of the IRB Chair or convened IRB increase the risk to the subject; or
- Enrollment of research subjects while study approval has lapsed.
Significant Financial Interest -means anything of economic or monetary value that to an independent observer would be or reasonably appear to be affected by research. Please refer to the University of Virginia Policy and Procedures For Oversight of Individual Financial Interests in Research for a more comprehensive definition of significant financial interest.
Significant Risk (SR) Device -An SR device study is defined as a study of 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.
Single-masked Design - Typically, a study design in which the investigator, but not the subject, knows the identity of the treatment assignment. Occasionally the subject, but not the investigator, knows the assignment. Sometimes called "single-blind design."
Site Visit - A visit by agency officials, representatives, or consultants to the location of a research activity to assess the adequacy of IRB protection of human subjects or the capability of personnel to conduct the research.
Sponsor - a person or other entity that initiates a research study, but that does not actually conduct the investigation, i.e., the test article is administered or dispensed to, or used involving, a subject under the immediate direction of another individual. A person other than an individual (e.g., a corporation or agency) that uses one or more of its own employees to conduct an investigation that it has initiated is considered to be a sponsor (not a sponsor-investigator), and the employees are considered to be investigators.
Sponsor-investigator - means an individual who both initiates and actually conducts, alone or with others a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject. The term does not include any person other than an individual, e.g., corporation or agency.
Statistical Significance - A determination of the probability of obtaining the particular distribution of the data on the assumption that the null hypothesis is true. Or, more simply put, the probability of coming to a false positive conclusion.
Surveys - Studies designed to obtain information from a large number of respondents through written questionnaires, telephone interviews, door-to-door canvassing, or similar procedures.
Suspension – the temporary closing of a human research project or discontinuing an investigator’s or key personnel’s privilege to conduct or to participate in the conduct of human research at the University of Virginia. The suspension may be partial in that certain activities may continue while others may stop or it may be complete in that no activity related to the human research or related to the privilege to conduct or participate in the conduct of human research may proceed. The IRB will make this determination.
Termination – the ending of all activities related to a human research project or an investigator’s or key personnel’s privilege to conduct or to participate in the conduct of human research at the University of Virginia except the continuation of follow-up activities necessary to protect subject safety.
Test article - means any drug (including a biological product for human use), medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under the act or under sections 351 and 354-360F of the Public Health Service Act (42 U.S.C. 262 and 263b-263n).
Therapy - Treatment intended and expected to alleviate a disease or disorder.
Unanticipated problem involving risks to subjects or others – any problem that was serious, unanticipated, and related, and affects the safety and welfare of current or future subjects or others involved with the research. Previously unforeseeable based on the information provided to the IRB.
Unexpected adverse experience (UAE) – Any adverse experience associated with the use of the drug/device, the specificity or severity of which is not consistent with the current investigator brochure; or, if an investigator brochure is not required or available, the specificity or severity of which is not consistent with the risk information provided to subjects and the IRB.
Vaccine - A biologic product generally made from an infectious agent or its components — a virus, bacterium, or other microorganism — that is killed (inactive) or live-attenuated (active, although weakened). Vaccines may also be biochemically synthesized or made through recombinant DNA techniques.
Variable – an element or factor that the research is designed to study, either as an experimental intervention or a possible outcome of that intervention.
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 active.
Vulnerable Subjects/Participants — Individuals who lack the capacity to provide informed consent or whose willingness to participate in research may be unduly influenced by others. Vulnerable subjects include, for example, children, prisoners, individuals with emotional or cognitive disorders/impairments, and economically or educationally disadvantaged persons. (45 CFR 46.111 (a)(3); 45 CFR 46.111 (b); 45 CFR 46 Subparts B, C and D).
Witness – Impartial, non-involved observer of the consent process for enrollment into a research study.