Source: https://oprs.research.illinois.edu/education-training/glossary-terms
Timestamp: 2018-02-21 03:31:37
Document Index: 464874011

Matched Legal Cases: ['art 58', 'art 46', '§360', '§513', '§116', '§26', '§26', '§312', '§201']

Glossary of Terms | Office for the Protection of Research Subjects
Pharmacological substances that have the potential for creating abusive dependency. Abuse-liable substances can include both illicit drugs (e.g., heroin) and licit drugs (e.g., methamphetamines).
American College of Sports Medicine. A sport-related organization of persons from a wide variety of occupations: sport science doctors, physiologists, researchers, coaches, trainers, and other practitioners and instructors. The ACSM's Mission Statement is to "promote and integrate scientific research, education, and practical applications of sports medicine and exercise science to maintain and enhance physical performance, fitness, health, and quality of life."
Means the Administrator of the Environmental Protection Agency and any other officer or employee of the Environmental Protection Agency to whom authority has been delegated by the Administrator.
Any undesirable and unintended, although not necessarily unexpected, result of therapy or other intervention (e.g., headache following spinal tap or intestinal bleeding associated with aspirin therapy).
Any physical, psychological or social harm to subjects during the course of research.
Is defined as an unproved assertion of non-compliance.
The quality or state of being anonymous, unknown, or not identifiable.
A child's affirmative agreement to participate in research. Mere failure to object, absent affirmative agreement, should not be construed as assent.
The scope and diversity of research areas in the behavioral and social sciences is quite broad. Some research is readily applicable to human affairs; other studies may broaden understanding without any apparent or immediate application. Some research is designed to test hypotheses derived from theory; other research is primarily descriptive. Still other research may be directed at evaluating an intervention or social program. Behavioral research involving human subjects generates data by means of questionnaires, observation, studies of existing records, and experimental designs involving exposure to some type of stimulus or intervention.
A valued or desired outcome; an advantage
A biological or related product derived from living sources (e.g., humans, animals, microorganisms) and regulated by the FDA, including blood, vaccines, allergenic, 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.
(1) Of or related to life or to living organisms; (2) A drug derived from a biological source.
Biomedical research employs many methods and research designs. Studies designed to evaluate the safety, effectiveness, or usefulness of an intervention include research on therapies (e.g., drugs, diet, exercise, surgical interventions, or medical devices), diagnostic procedures (e.g., CAT scans or prenatal diagnosis through amniocentesis, chorionic villi testing, and fetoscopy), and preventive measures (e.g., vaccines, diet, or fluoridated toothpaste). Research on normal human functioning and development can include studies of the human body while exercising, fasting, feeding, sleeping, or learning, or responding to such things as stress or sensory stimulation. Subjects of some biomedical studies engage in ordinary tasks while measurement of physiological and bodily functions are made. Some biomedical studies, particularly those conducted to evaluate new therapies or treatments, use such rigorous experimental methods as random assignment to treatment and control groups.
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 (See also: retrospective studies.).
The official notification by the institution to the supporting Department or Agency, in accordance with the requirements of this policy, that a research project or activity involving human subjects has been reviewed and approved by an IRB in accordance with an approved assurance.
In Illinois a child is defined as an individual who has not attained 18 years of age.
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.
[45 CFR 46.402(a)]
Code of Federal Regulations. A cumulation of federal executive agency regulations organized into 50 Titles and published in the Federal Register as they are promulgated.
Any experiment in which a test article 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))
Entities engaged in human subjects research by virtue of subject accrual, transfer of identifiable information, and/or in exchange of something of value, such as material support (e.g., money, drugs, or identifiable specimens, coauthorship, intellectual property, or credits).
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.)
A conflict of interest occurs when an IRB member is in a position to advance the IRB member's own interest or that of the IRB member's family or others to the potential detriment of any human subject involved in the research under review.
Is defined as a pattern of non-compliance that, in the judgment of the IRB Chair or convened IRB, suggests a likelihood that instances of non-compliance will continue without intervention. Continuing non-compliance also includes failure to respond to a request to resolve an episode of non-compliance.
The Department of Health and Human Services (HHS) Regulations, 45 CFR 46, require at Section 46.109(e) that "an IRB shall conduct continuing review …at intervals appropriate to the degree of risk, but not less than once per year…" Continuing review must be substantive and meaningful. Review by the convened IRB, with recorded vote, is required unless the research is otherwise appropriate for expedited review under Section 46.110.
Departamental Review Bodies
Committees or persons representing a UIUC department involved in human subjects research, and which are delegated the authority to review applications for such research if it is minimal risk and is not externally funded.
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. (See also: fieldwork.)
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].
human subjects research that is specifically excluded from the application of 45 CFR 46 is termed exempt and is described at 45 CFR 46.101.
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) 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 non-clinical laboratory studies. An experiment, as defined in 21 CFR 312, includes any use of a drug other than the use of a marketed (approved) drug in the course of medical practice.
Human Subject Research as defined by FDA regulations
Term often used to denote a therapy (drug, device, procedure) that is unproved 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. (See also: research.)
A true experimental study is one in which subjects are randomly assigned to groups that experience carefully controlled interventions manipulated by the experimenter according to a strict logic allowing causal inference about the effects of the interventions under investigation. (See also: quasi-experimental study.)
The date after which a protocol is no longer approved for use with human subjects.
At the University of Illinois at Urbana-Champaign, any research funded by an agency external to the University of Illinois and its subunits.
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)
The federal policy that provides regulations for the involvement of human subjects inresearch. The Policy applies to all research involving human subjects conducted, supported, or otherwise subject to regulation by any federal department or agency that takes appropriate administrative action to make the Policy applicable to such research. (Also known as the "Common Rule.")
The product of conception from 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. (See also: embryo.)
Is defined as an allegation of non-compliance that is proven true or a report of non-compliance that is clearly true. (For example, a finding on an audit of an unsigned consent document, or an admission of an investigator that the protocol was willfully not followed would represent reports of non-compliance that would require no further action to determine their truth and would therefore represent findings of non-compliance.)
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. 510(k) is the section of the Food, Drug and Cosmetic Act that describes premarket notification; hence the designation "510(k) device."
Generally are not regulated as drugs. However, those that are intended or promoted to be used in the diagnosis, cure, mitigation, treatment or prevention of disease are considered drugs.
See: Title 45 Code of Federal Regulations Part 46.
Certain FDA statutory provisions designed to control the safety of marketed drugs anddevices. The general controls include provisions on adulteration, misbranding, banned devices, good manufacturing practices, notification and record keeping, and other sections of the Medical Device Amendments to the Food, Drug and Cosmetic Act [21 U.S. Code §360(c) (Food, Drug and Cosmetic Act §513)].
Knowledge "expressed in theories, principles, and statements of relationships" that can be widely applied to our experiences [the Belmont Report]. The term "generalizable knowledge" is used to distinguish the results of research from the results of nonresearch activities such as "practice" activities. "For the most part, the term 'practice' refers to interventions that are designed solely to enhance the well-being of an individual patient or client. By contrast, the term "research" designates an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge [the Belmont Report]."
In Illinois a “Guardian” of a minor means 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 a permanent effect on the life and development of the minor, and to be concerned with his or her general welfare.
See: DHHS
An oath of ethical professional behavior sworn by some new physicians and attributed to Hippocrates, a Greek physician of about the Fifth Century BC. A central tenet of the oath is "do no harm." Excerpts from the oath: "I swear…that...I will follow that system of regimen which, according to my ability and judgment, I consider for the benefit of my patients, and abstain from whatever is deleterious and mischievous. I will give no deadly medicine to any one if asked, nor suggest any such counsel…Into whatever houses I enter, I will go into them for the benefit of the sick, and will abstain from every voluntary act of mischief and corruption….Whatever, in connection with my professional practice, or not in connection with it, I see or hear in the life of men, which ought not to be spoken of…I will not divulge, as…all such should be kept secret."
See: human immunodeficiency virus.
Human Subject Research as defined by DHHS regulations
An individual who is or becomes a subject in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient. In the case of a medical device, a human subject/participant also means a human on whose specimen an investigational device is used.
For the purposes of this policy “human subject research” is defined as an activity that meets the definition of “research” and involves “human subjects” as defined either by DHHS regulations or by FDA regulations (or other applicable funding agencies).
See: Investigational Device Exemptions.
Refers to a person's mental status and means inability to understand information presented, to appreciate the consequences of acting (or not acting) on that information, and to make a choice. Often used as a synonym for incompetence. (See also: incompetence.)
Technically, a legal term meaning inability to manage one's own affairs. Often used as a synonym for incapacity. (See also: incapacity.)
[Federal Policy §116; 21 CFR 50.20 and 50.25].
In the place of a parent; instead of a parent; charged with a parent's rights, duties, and responsibilities.
Any public or private entity or agency (including federal, state, and local agencies).
Confined, either voluntarily or involuntarily (e.g., in a hospital, prison, or nursing home).
Intervention includes both physical procedures (e.g., venipuncture) by which data are gathered and manipulations of the subject (e.g., by deception) or the subject's environment (e.g., by introducing extreme heat) that are performed for research purposes.
A 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.
An IDE exempts an unapproved or uncleared device (or an approved or cleared device for an unapproved or uncleared indication) in a research study involving humans (i.e., an IDE is an investigational exemption) from certain statutes and regulations. With this exemption, the unapproved or uncleared device can be shipped and used in human research.
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.
An IND exempts an investigational new drug from pre-marketing approval requirements that would otherwise by applicable and allows the drug to be lawfully shipped for the purpose of conducting clinical investigations of that drug.
(21 CFR 312.1(a))
An Institutional Review Board established in accord with and for the purposes expressed in this policy.See also: Institutional Review Board
Means diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted and diseases or conditions with potentially fatal outcomes, where the end point of clinical trial analysis is survival. The criteria for life threatening do not require the condition to be immediately life threatening or to immediately result in death. Rather, the subjects must be in a life-threatening situation requiring intervention before review at a convened meeting of the IRB is feasible.
A significant change to a protocol where subjects would be engaging in activities not previously approved during the review process or where there is an increased level of risk to the physical, emotional, or psychological well-being of participants, especially in relation to the loss of confidentiality.
Study designs comparing two or more interventions in which either the investigators, the subjects, or some combination thereof do not know the treatment group assignments of individual subjects. Sometimes called "blind" study designs. (See also: double-masked design; single-masked design.)
Medical Disability (ies)
See: metabolic equivalent
The oxygen cost of energy expenditure measured at supine rest (1 MET = 3.5 ml O2 per kg of body weight per minute); multiples of MET are used to estimate the oxygen cost of activity, e.g., 3 to 5 METs for light work; more than 9 METs for heavy work [Stedman's Medical Dictionary, 26th ed.]
[See 45 CFR 46.303(d)]
Protocol modifications that might include minor wording changes in the consent form, changes in compensation, time of participation, or subject recruitment, or the use of a new investigation site that is not materially different from a previously approved site. There may also be changes to other parameters whereby the investigator provides the subjects with more accurate information as a result of additional experience with the protocol.
A formal document filed with OHRP that outlines specifically how an IRB will comply with DHHS regulations for the protection of human subjects (45 CFR 46), in accordance with the federal policy.
See: NIH.
See: new drug application.
Information of a private nature that is not available to the general public, not located in a public place, or not open and available to common use or observation.
Is defined as failure to comply with any of the regulations and policies described in this document and failure to follow the determinations of the IRB. Non-compliance may be minor or sporadic or it may be serious or continuing.
A device not meeting the definition of SR device. Examples of significant and nonsignificant risk devices are available at:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDo...
Research that has no likelihood or intent of producing a diagnostic, preventive, ortherapeutic benefit to the current subjects, although it may benefit subjects with a similar condition in the future.
Means any research with human subjects that does not meet the definition of research involving intentional exposure of a human subject in §26.202(a).
§26.202(a)
New name for the OPRR (Office for Protection from Research Risks) after it was moved out of the NIH and directly under the purview of the DHHS in June 2000; this office is currently responsible for implementing DHHS regulations governing human subjects research.
A child's biological or adoptive parent.
The agreement of parent(s) or legal guardian(s) to the participation of their child or ward in research.
The scientific discipline that studies the action of drugs on living systems (animals or human beings)
Phase 1,2,3,4 Drug Trials
Phase 1 trials include the initial introduction of an investigational new drug into humans. These studies are typically conducted with healthy volunteers; sometimes, where the drug is intended for use in patients with a particular disease, however, such patients may participate as subjects. Phase 1 trials are designed to determine the metabolic and pharmacological actions of the drug in humans, the side effects associated with increasing doses (to establish a safe dose range), and, if possible, to gain early evidence of effectiveness; they are typically closely monitored. The ultimate goal of Phase I trials is to obtain sufficient information about the drug's pharmacokinetics and pharmacological effects to permit the design of well-controlled, sufficiently valid Phase 2 studies. Other examples of Phase 1 studies include studies of drug metabolism, structure-activity relationships, and mechanisms of actions in humans, as well as studies in which investigational drugs are used as research tools to explore biological phenomena or disease processes. The total number of subjects involved in Phase 1 investigations is generally in the range of 20-80.
[21 CFR §312.85].
Public Health Service. Part of the US Department of Health and Human Services, it includes FDA,NIH, CDC, SAMHSA, and HRSA.
A research project that is tested or "piloted" on relatively few subjects so that preliminary data and parameters can be assessed before a full-blown study is developed.
A membranous, highly vascularized organ of metabolic interchange between a fetus and its mother; partly of embryonic origin and partly of maternal origin [Stedman's Medical Dictionary, 26th ed.].
The period of time from confirmation of implantation of a fertilized egg within the uterus until thefetus has entirely left the uterus (i.e., has been delivered). Implantation is confirmed through a presumptive sign of pregnancy such as missed menses or a positive pregnancy test [45 CFR 46.203(b)]. This "confirmation" may be in error, but, for research purposes, investigators would presume that a living fetus was present until evidence to the contrary was clear. Although fertilization occurs a week or more before implantation, the current inability to detect the fertilization event or the presence of a newly fertilized egg makes a definition of pregnancy based on implantation necessary.
A PMA is the most stringent type of marketing application for medical devices; FDA approves a PMA based on presence of sufficient valid scientific evidence and reasonable assurance that the device is safe and effective for its intended use. Once approved, it can be marketed and sold within its approved labeling.
A 510(k) application is submitted to FDA before a manufacturer plan to market a device. If the FDA agrees that the new device is substantially equivalent to a legally marketed device for which a PMA is not required, the manufacturer may market it immediately. FDA does not require clinical data for most 510(k)s. However, if clinical data are necessary to demonstrate equivalence, the clinical study must comply with IDE, IRB and human subject protection regulations.
Any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing.
Having control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others.
Private information includes information about a subject that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place. It also refers to information that has been provided for specific purposes by an individual with the reasonable expectation that it 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.]
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 orintervention but may be purely observational or involve only the collection of data.
Pertaining to an entire community, state, or nation; proceeding from, relating to, or affecting the whole body of people. Open to all; notorious. [Black's Law Dictionary, 5th ed.].
A study that is similar to a true experimental study except that it lacks randomassignments of subjects to treatment groups. (See also: experimental study.)
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.
An institutional committee responsible for the use ofradioactive drugs in human subjects for research purposes. Research involving human subjects that proposes to use radioactive drugs must meet various FDA requirements, including limitations on the pharmacological dose and the radiation dose. Furthermore, the exposure to radiation must be justified by the quality of the study and the importance of the information it seeks to obtain. The committee is also responsible for continuing reviewof the drug use to ensure that the research continues to comply with FDA requirements, including reporting obligations. The committee must include experts in nuclear medicine and the use of radioactive drugs, as well as other medical and scientific members.
[21 CFR 36.1]
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 used in the examination. The chemical structure of radiopaque contrast agents can produce a variety of adverse reactions, some of which may be severe—and possibly life-threatening—in certain individuals.
Random, Randomly, Random Assignment, Randomization, Randomized
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 experimentalresearch because it makes more likely the probability that differences observed between subject groups are the result of the experimental intervention.
"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 [Holtzman (1989), p. 1]. Recombinant DNA technology is also used to develop diagnostic screens and tests, as well as drugs and biologics for treating diseases with genetic components.
An event is “related to the research procedures” if in the opinion of the principal investigator, it was more likely than not to be caused by the research procedures or if it is more likely that not that the event affects the rights and welfare of current participants.
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.
Payment for participation in research. (Note: It is wise to confine use of the term "compensation" to payment or provision of care for research-related injuries.) (Compare: compensation.)
A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition may be funded or unfunded, or may be conducted as a component of another program not usually considered research. For example, demonstration and service programs may include evaluation components, which constitute research activities under this definition.
An activity, for research purposes, where there is an intervention or interaction with a human being for the primary purpose of obtaining data regarding the effect of the intervention or interaction (32 CFR 219.102(f), reference (c)). Examples of interventions or interactions include, but are not limited to, a physical procedure, a drug, a manipulation of the subject or subject's environment, the withholding of an intervention that would have been undertaken if not for the research purpose. This definition does not include:
• Activities carried out for purposes of diagnosis, treatment, or prevention of injury and disease in members of the Armed Forces and other mission essential personnel under Force Health Protection programs of the Department of Defense.
• Authorized health and medical activities as part of the reasonable practice of medicine or other health professions.
• Monitoring for compliance of individuals and organizations with requirements applicable to military, civilian, or contractor personnel or to organizational units. This includes such activities as drug testing, occupational health and safety monitoring, and security clearance reviews.
Human Subject Research as defined by the Department of Defense
Research involving intentional exposure of a human subject
Means a study of a substance in which the exposure to the substance experienced by a human subject participating in the study would not have occurred but for the human subject's participation in the study.
Responsible Project Investigator - a non-visiting member of the University of Illinois at Urbana-Champaign faculty or staff who takes ultimate responsibility for the protection of the subjects and the conduct of the human subjects’ research described on his or her IRB application.
An ethical principle discussed in the Belmont Report requiring that individualautonomy be respected and that persons with diminished autonomy be protected.
A US Cabinet Officer. In the context of DHHS-conducted or -supported research, usually refers to the Secretary of Health and Human Services.
Any adverse experience occurring at any dose or level of participation that results in any of the following outcomes: death, a life-threatening experience, hospitalization or prolongation of existing hospitalization, a persistent or significant disability or capacity, or a congenital anomaly or birth defect.
Seroposivity
Indicating the presence of immunological evidence of a specific infection [Stedman's Medical Dictionary, 26th ed.].
Is defined as failure to follow any of the regulations and policies described in this document or failure to follow the determinations of the IRB and which, in the judgment of either the IRB Chair or the convened IRB, increases risks to participants, decreases potential benefits, or compromises the integrity of the human research protection program. Research being conducted without prior IRB approval is considered serious noncompliance.
Means diseases or conditions that cause major irreversible morbidity. Examples of severely debilitating conditions include blindness, loss of arm, leg, hand or foot, loss of hearing, paralysis or stroke.
Significant risk device (SR) is an investigational device that: (1) is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject; (2) is for use in supporting or sustaining human life and represents a potential for serious risk to the health, safety, or welfare of a subject; (3) is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject; or (4) otherwise presents a potential for serious risk to a subject. The SR determination encompasses the proposed use and not the device alone (e.g., need for additional procedures, such as surgical implantation, as part of the study should be included in risk assessment.
A person or entity that initiates a clinical investigation of a drug—usually the drug manufacturer or research institution that developed the drug. The sponsor does not actually conduct the investigation, but rather distributes the new drug to investigators and physicians for clinical trials. The drug is administered to subjects under the immediate direction of an investigator who is not also a sponsor. A clinical investigator may, however, serve as a sponsor-investigator. The sponsor assumes responsibility for investigating the new drug, including responsibility for compliance with applicable laws and regulations. The sponsor, for example, is responsible for obtaining FDA approval to conduct a trial and for reporting the results of the trial to the FDA.
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. If the probability is less than or equal to a predetermined value (e.g., 0.05 or 0.01), then the null hypothesis is rejected at that significance level (0.05 or 0.01).
Express IRB provisions that must be satisfactorily addressed by the RPI before a human subjects research project can be approved and any involvement of human subjects in the research may begin. Under no circumstances do stipulations constitute contingent approval of the research project—approval is neither given nor implied until the RPI has received written notice of IRB approval.
An activity that involves a prospective research plan which incorporates data collection, both quantitative and qualitative, and data analysis to answer a research question. Investigations designed to develop or contribute to generalizable knowledge are those designed to draw general conclusions (i.e., knowledge gained from a study may be applied to populations outside of the specific study population), inform policy, or generalize findings.
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.
See: 45 CFR 46
Include subject complaints, withdrawal from research, and breaches of subject confidentiality.
Unanticipated Problem Involving Risks to Participants or Others (Unanticipated Problem)
Any event or information that (1) was unforeseen and (2) indicates that the research procedures caused harm to participants or others or indicates that participants or others are at increased risk of harm.
Include any information discovered during the course of research that may affect the risk–benefit assessment for the research.
An event is “unexpected” when its specificity and severity are not accurately reflected in the informed consent document.
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.
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. The Secretary may, from time to time, take in account medical advances and publish in the Federal Register guidelines to assist in determining whether a neonate is viable for purposes of 45 CFR 46. If a neonate is viable, then it may be included in research only to the extent permitted and in accordance with the requirements of 45 CFR 46.
When referring to a delivered or expelled fetus, the term "viable infant" means likely to survive to the point of sustaining life independently, given the benefit of available medical therapy [45 CFR 46.203(d)]. This judgment is made by a physician. In accordance with DHHS regulations, the Secretary, DHHS, may publish guidelines to assist in the determination of viability. Such guidelines were published in 1975, and specify an estimated gestational age of 20 weeks or more and a body weight of 500 grams or more as indices of fetal viability [Federal Register 40 (August 8, 1975): 33552]. These indices depend on the state of present technology and may be revised periodically. (See also: nonviable fetus.)
A person placed by the court under the care of a guardian [Black's Law Dictionary, 5th ed.].
Material originally collected for clinical or diagnostic purposes but that is no longer needed for that purpose.