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Common Research Terminology

This page contains a list of common terms used in reference with Human Subject Protection.  For a list of Lay Terms to use in place of Medical terms when writing a consent letter please click the following link...Glossary of Lay Terms.

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

A

Adverse event:  Any unanticipated problem involving risks to human research participants.  An undesirable and unintended, although not necessarily unexpected, result arising during the course of a research protocol.

Adverse event reports:  Researcher reports of all serious and adverse events, injury and deaths given to the sponsor, the IRB, the FDA, and the NIH.

Advertising:  One mechanism or method used by researchers to recruit subjects for research studies.

Alternatives:  Options that exist for a subject who is thinking about participating in research.

ARENA:  Applied Research Ethics National Association: a membership organization for individuals interested in ethical issues relating to medicine and research.

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.

Assurance: Renewable permit granted by a Federal Department to an institution to conduct research in compliance with government standards.  A formal written, binding commitment that is submitted to a federal agency in which an institution promises to comply with regulations governing the protection of human subjects in research. Assurance is the word used in the Federal Policy (Common Rule).

Authorized Institutional Official: See “Institutional Official.”

Autonomy: See “Respect for Persons.”

B

Belmont Report: A statement of basic ethical principles governing research involving human subjects issued in 1978 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.  Cornerstone document of ethical principles and Federal regulation of protection for research participants based on respect for persons, beneficence and justice.  Applications of these three ethical principles to the conduct of research leads to consideration of required informed consent and privacy and confidentiality; risk/benefit assessment and scientific merit; and the selection of research participants.

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 research benefit is considered to be something of health-related, psychological, or other value to an individual research participant, or something that will contribute to the acquisition of generalizable knowledge.  Money or other compensation for participation in research is not considered to be a benefit, but rather compensation for research-related inconveniences.

C

Certificate of Confidentiality: A Certificate of Confidentiality protects the compelled release of identifiable information about research subjects in any legal proceeding. These documents are issued by the DHHS and can be requested for all research, regardless of funding source [42 USC 241(d)].  VA does not issue its own Certificates of Confidentiality.

Certification: The official notification by the institution to the supporting Department or Agency, in accordance with the requirements of 45CFR46, that a research project or activity involving human participants has been reviewed and approved by an Institutional Review Board in accordance with an approved assurance.

Chair: The person who leads the activities of the IRB.

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

Clinical Investigation: Any experiment that involves a test article and one or more human subjects that is subject to Food and Drug Administration (FDA) requirements for research or marketing permits [21 CFR Part 50.3(c) and 56.102(c)].

Clinical Trial: A controlled study involving human subjects designed to contribute to generalizable knowledge about the safety and/or effectiveness of an intervention or treatment.

Coercion: The act of inducing or pressuring an individual to consent to participate in research or to stay in research.

Cognitive Impairment: Some disorder that affects cognitive or emotional functions to the extent that capacity for judgment and reasoning is significantly diminished.

Common Rule: The Federal Policy for the Protection of Human Subjects was adopted in 1991 and covers research supported by the Departments of Agriculture, Energy, Commerce, HUD, Justice, Defense, Education, Veterans Affairs, Transportation, and HHS as well as NSF, NASA, EPA, AID, Social Security Administration, CIA, and the Consumer Product Safety Commission.  The provisions are identical to the DHHS Regulations (45 CFR 46, Subpart A).

Compensation: Refers to payment or other benefits that will be given to subjects who volunteer to participate in research protocols.

Competence: The 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.

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.

Consent: Agreement to do something. Informed consent is agreement to do something based upon a complete understanding of that task.

Consent form: Contains all relevant research information explained in lay terms and documents voluntary participation.  Information includes a statement about potential risks and must address each of the eight elements required by the regulations.  This is presented to and signed by the participant, and retained in the participant's medical record.

Control: 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 the study.

Continuing Review: The regulatory requirement that the Institutional Review Board (IRB) review research at intervals not greater than one year. The IRB may review research at more frequent intervals [45 CFR 46.109(e); 21 CFR 56.109(f)].

D

Data: Information organized for analysis or used as the basis for decision-making.

Data and Safety Monitoring Board (DSMB): An independent committee whose function it is to provide data and safety monitoring of a research study.  DSMBs are required by NIH for all Phase III clinical trials, but may also be appropriate for Phase I and Phase II clinical trials if the studies have multiple clinical sites, are blinded (masked), or employ particularly high-risk interventions or vulnerable populations.  The Data and Safety Monitoring Board looks for any information that might warrant modification or termination of the trial or notification of subjects about new information that might affect their willingness to continue in the trial.

Data and Safety Monitoring Plan: A plan with a general description of data and safety monitoring of a research study.  This is trial-specific, developed by the researcher, included in the protocol, and submitted to the IRB for review and approval before the study begins.

Deception Study: A research study that incorporates in the design a technique for intentionally misleading a human subject during the course of the study to obtain certain results.  The subject is debriefed after the study ends or after their participation ends.

Declaration of Helsinki: Statement of ethical principles first published in 1964 by the World Medical Association to define the rules for therapeutic and non-therapeutic research.  It has been widely adopted by medical associations worldwide and has been revised numerous times.

Department or Agency Head: The head of any Federal Department or Agency and any other officer or employee of any Department or Agency to whom authority has been delegated.

DHHS: Acronym for U.S. Department of Health and Human Services.

DSMB: Acronym for Data and Safety Monitoring Board.

E

Emancipated Minor: Defined by law, this refers to the legal status of a person who has not yet attained the age of legal competency but who is entitled to adult status for certain matters.

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.

Exemptions: The Federal Policy for the Protection of Human Subjects contains six exemptions. Research falling under one of these exemptions is not required to undergo IRB review and the investigator is not required to abide by the requirements for obtaining information consent [See 45 CFR 46.101(b)]. FDA regulations contain an exemption from IRB review requirements for the emergency use of a test article [21 CFR 56.104(c)] and for certain taste and food quality evaluations and consumer acceptance studies [21 CFR 56.104(d)].

Expected adverse event: For approved and marketed drugs or devices, those adverse events described in the approved Package Insert (Label).  For investigational new drugs or devices, those adverse events described in the FDA Investigator's Brochure.  In clinical research studies, information on expected adverse events are summarized in the protocol and in the consent form.

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 convened IRB. Federal regulations permit expedited review for: (1) certain kinds of research involving no more than minimal risk and that fall within a category listed on the November 9, 1998 Federal Register [63 FR 60364]; and, (2) for minor changes in previously approved research [45 CFR 46.110; 21 CFR 56.110].

Experiment: Generally, this refers to an intervention or interaction that is unproven and not yet scientifically validated.

F

FDA: Acronym for the Food and Drug Administration, a component of DHHS.

Federal Policy: Another short reference, along with the phrase “Common Rule,” for the Federal Policy for the Protection of Human Subjects in Research [56 FR 28003].

Federal Register: The government’s publication in which final and proposed rules or notices are published.

Fetus: The product of conception from the time of implantation (as evidenced by any of the presumptive signs of pregnancy, such as missed menses, or a medically acceptable pregnancy test), until a determination is made, following expulsion or extraction of the fetus, that it is viable.  Refer to Subpart B of 45 CFR Part 46 for specific findings that are required for research involving fetuses.

Food and Drug Administration (FDA): An agency within the Department of Health and Human Services (DHHS) that enforces the Food, Drug and Cosmetics Act and related Federal public health laws.

Full Board Review: Review of proposed research at a convened meeting of the IRB, at which a majority of the membership of the IRB are present, including at least one member whose primary concerns are in a nonscientific area [45 CFR 46.109; 21 CFR 56.108].

G

Grant: Financial support provided for a research study designed and proposed by the principal investigator.  May be public or private funds.

Guardian: An individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care.

H

Helsinki Declaration: See Declaration of Helsinki.

Human in Vitro Fertilization: Any fertilization involving human sperm and ova that occurs outside the human body.

Human participant (subject): An individual who is the object of study in a research project. Under the Federal Policy (Common Rule), human subject means a living individual about whom an investigator conducting research obtains: (1) data through intervention or interaction with the individual; or (2) identifiable private information [45 CFR 46.102(f)]. Under FDA regulations, “human subject” means an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy individual or a patient [21 CFR 50.3(g) and 56.102(e)].

Human Protections Administrator: An individual who has responsibility for day-to-day operation and implementation of the institution’s program for protecting human subjects. The institutional title and duties of the Human Protections Administrator may vary widely from institution to institution. For example, an institutional compliance officer, head IRB administrator, or some other individual might fill this role, depending upon the nature of the institution. In VA this position may be the ACOS/R&D, the A/O, or the IRB Administrator.   In any case, the Human Protections Administrator should have detailed knowledge of institutional protection mechanisms and be readily available for consultation with federal officials and institutional personnel. The IRB Chairperson should not serve as the Human Protections Administrator.

I

IDE: Acronym for Investigational Device Exemption.

IEC: Acronym for Independent Ethics Committee.

Incapacity: 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.

Inclusion criteria: A list of criteria that must be met by all study participants.  The criteria that establish whether a person is eligible to participate in a clinical trial.

Incompetence: A legal term meaning inability to manage one’s own affairs.

IND: Acronym for Investigational New Drug Application.

Independent Ethics Committee (IEC): The equivalent of an IRB under the International Conference on Harmonization Guidelines for Good Clinical Practice.

Informed Consent: The process of information exchange between researcher and participant prior to written consent to participate in biomedical research.  Information includes recruitment information, written materials as well as verbal instructions, questions and answer sessions about the research and its procedures.  Participants are given the opportunity to choose research involvement based on information, comprehension, and willingness to volunteer.

Institution: Any public or private entity or Agency (including federal, state, and other agencies) [45 CFR 46.102(b); and, 21 CFR 50.3(h) and 56.102(f)].).  The location of research being done.  Has ultimate responsibility for human participation regulation compliance.

Institutional Official: The individual at an institution who is responsible for ensuring the effective administration and implementation of the institution’s system for the protection of human subjects.

Institutional Review Board (IRB): An IRB established in accordance with and for the purposes expressed in 45CFR46 and 21CFR56.  Insures that the data reported is credible and accurate and that the participant's rights and confidentiality are protected.  A review body established by regulation to protect the welfare of human subjects recruited to participate in research.

Institutional Review Board Approval: The determination of the IRB that the research 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.

Interaction: Includes communication or interpersonal contact between researcher and participant.

Intervention: Includes both physical procedures by which data are gathered (e.g., venipuncture) and manipulations of the participant or the participant's environment that are performed for research purposes.

Investigational Device Exemption (IDE): Exemptions from certain regulations found in the FDA, Medical Device Amendments that allow shipment of unapproved devices for use in clinical investigations [21 CFR 812.20].

Investigational New Drug Application (IND): An application to conduct a clinical investigation involving a drug not yet determined by the Food and Drug Administration to be safe and effective for a particular use in the general population and not yet licensed for marketing [21 CFR 312.1].

Investigator: The individual who actually conducts a research investigation [21 CFR 50.3(d) and 56.102(h)].

IRB: Acronym for Institutional Review Board. 

J

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.

L

Legally Authorized Representative: An individual or judicial or other body authorized under applicable law to consent on behalf of a prospective participant to his/her participation in the procedure(s) involved in the research.  For research purposes, only select states permit a LAR to consent for research participation [45 CFR 46.102(c); 21 CFR 50.3(e)].

M

Member: A person who is listed on the roster of an IRB as a voting participant in IRB deliberations and actions.

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 [45 CFR 46.102(i); and, 21 CFR 50.3(k) and 56.102(j)].

Minimal Risk (DHHS Subpart C - prisoners): The probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons [45 CFR 46. 303(d)].

Monitoring: A mechanism for keeping track of any part of the research process: data analysis, recruitment of subjects, informed consent process, to ensure its compliance with Institutional Review Board dictates and the federal regulations.

N

National Bioethics Advisory Commission (NBAC): A Presidentially appointed commission that issues reports and makes recommendations relating to the protection of human subjects in research.

National Institutes of Health (NIH): The Federal Government's primary agency for advancing knowledge in biomedical and behavioral sciences in order to understand and treat human diseases.  The NIH is part of the U.S. Public Health Service (PHS) which, in turn, is an agency within the DHHS.

National Research Act: Created by the National Commission for Protection of Human Subjects of Biomedical and Behavioral research in 1974; mandated review of studies by institutional review boards and participant protection by informed consent.

Non-Affiliated Member: Member of an IRB who has no ties (and whose immediate family members have no ties) to the parent institution, its staff, or faculty. This individual is usually from the local community [45 CFR 46.107(d); and 21 CFR 56.107(d)].

Non-English Speaking: Subjects for which English is a secondary language.  To meet the requirements of 21 CFR 50.20, the informed consent doucment should be in language understandable to the subject (or authorized representative).  A copy of a translated informed consent document must be given to non-English speaking subjects.

Non-Scientist: Member of an IRB who does not have a scientific background, but may be affiliated with the institution [45 CFR 46.107(c); and, 21 CFR 56.107(c)]. At least one non-scientist member must be present at convened meetings to approve research [45 CFR 46.108(b); and, 21 CFR 46.108(c)].

Normal Volunteers: Volunteer subjects in a research study who do not have the condition under study. The 1993 Office for Protection from Research Risks (OPRR) Guidebook defines normal volunteers as follows: “Normal” may not mean normal in all respects. For example, patients 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, patients with heart disease but without diabetes may be the “normals” in a study of diabetes complicated by heart disease [OPRR IRB Guidebook, 1993, G-9].

Notice of Proposed Rule-Making (NPRM): Pursuant to the Administrative Procedure Act, the government must typically issue a notice of a proposed rule before it issues the final rule. This affords the public the opportunity to comment on contemplated government action.

Nuremberg Code: A code of research ethics developed during the trials of Nazi war criminals following World War II and widely recognized as a standard during the 1950s and 1960s for protecting human subjects.

O

Office for Human Research Protection (OHRP): This office interprets and oversees implementation of the regulations regarding the Protection of Human Participants codified at Title 45, Part 46, of the Code of Federal Regulations (45CFR46) promulgated by the DHHS.  It is also responsible for providing guidance on ethical issues in biomedical and behavioral research.  The OHRP has oversight and educational responsibilities wherever DHHS funds are used to conduct or support research involving human participants.  It is located in the Office of the Secretary, Health and Human Services.

Office of Human Subjects Research (OHSR): Promotes and supports NIH's Intramural Research Program's (IRP) efforts to conduct innovative research which protects the rights and promotes the welfare of human participants; assists IRP researchers in understanding and complying with the ethical guidelines and regulatory requirements of research involving human participants.  Operates within the Office of the Deputy Director for Intramural Research (DDIR), National Institutes of Health (NIH).

Office for Protection from Research Risks (OPRR): Until June 2000, this office was within the DHHS as part of the National Institutes of Health (NIH). OPRR was responsible for the implementation of the DHHS regulations [45 CFR Part 46] governing research involving human subjects. The Office for Human Research Protections supercedes OPRR.

Oral Consent: Typically refers to informed consent that is obtained from a subject without use of a written informed consent document. 

P

Parent: A child's biological or adoptive parent.

Parental Permission: The agreement of one or both parents or a guardian to research involving a minor [45 CFR 46.402(c)].

Permission: The agreement of parent(s) or guardian to the participation of their child or ward in research.

Phase 1,2,3,4, Clinical 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).

Phase I trial: Phase 1 trials include the initial introduction of an investigational new drug into humans. These studies are typically conducted with healthy volunteers; however, where the drug is intended for use in patients with a particular disease, 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 1 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. Typically, Phase 1 investigations involve anywhere from 20-80 subjects [21 CFR 312.21(a)].

Phase II trial: Phase 2 trials include controlled clinical studies conducted to evaluate the drug’s effectiveness for a particular indication in patients with the disease or condition under study, and to determine the common short-term side effects and risks associated with the drug. These studies are typically well-controlled, closely monitored, and conducted with a relatively small number of patients, usually involving no more than several hundred subjects [21 CFR 312.21(d)].

Phase III trial: Phase 3 trials involve the administration of a new drug to a larger number of patients in different clinical settings to determine its safety, efficacy, and appropriate dosage. They are performed after preliminary evidence of effectiveness has been obtained, and are intended to gather necessary additional information about effectiveness and safety for evaluating the overall benefit-risk relationship of the drug, and to provide an adequate basis for physician labeling. In Phase 3 studies, the drug is used the way it would be administered when marketed. When these studies are completed and the sponsor believes that the drug is safe and effective under specific conditions, the sponsor applies to the FDA for approval to market the drug. Phase 3 trials usually involve several hundred to several thousand subjects [21 CFR 312.21(c)].

Phase 4 Clinical Trials: The FDA, when it gives market approval, may seek an agreement from the sponsor to conduct certain postmarketing studies to ascertain additional information about the drug’s risks, benefits, and optimal use. These studies could include, but would not be limited to, studying different doses or schedules of administration than were used in Phase 2 studies, use of the drug in other patient populations or other stages of the disease, or use of the drug over a longer period of time [21 CFR 312.85].

Placebo: In biomedical research, 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 the actual power of a drug. In social and behavioral research, a condition that mimics the experimental context but does not include the experimental manipulation under study. As in biomedical research, the control condition is used to confirm that observed effects are the result of the experimental manipulation rather than the research context itself.

Pregnancy: The period of time from confirmation of implantation of a fertilized egg within the uterus until the fetus 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 must presume that a living fetus is present until evidence to the contrary is 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.

Principal Investigator (PI): The person with primary responsibility for design and conduct of a research project.

Prisoner: 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 [45 CFR 46.303(c)].

Prisoner Representative: A member of an IRB who has appropriate background and experience to represent the interests and concerns of an individual who is involuntarily confined to an institution [45 CFR 46.304(b)].

Privacy: Concealment from others of information about oneself.

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 (e.g., a medical record).  Private information must be individually identifiable (i.e., the identity of the participant 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 participants.

Protocol: The formal design or plan of an experiment or research activity. 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.

Public Health Service (PHS): A division within the DHHS. PHS agencies include the National Institutes of Health, Centers for Disease Control, the Indian Health Service, and the Substance Abuse and Mental Health Services Administration.

Public Responsibility in Medicine and Research (PRIM&R): A non-profit organization that organizes conferences, workshops, and other activities to further the protection of human subjects in research.

R

Random Assignment: Assignment of subjects to different treatments, interventions, or conditions according to chance.

Recruitment: The act of selecting and enrolling research participants with the proper inclusion criteria.

Research: Under the Federal Policy and the DHHS Subpart A, research is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.  Activities which meet this definition constitute research for purposes of 45CFR46, whether or not they are conducted or supported under a program which is considered research for other purposes.  For example, some demonstration and service programs may include research activities.  Under FDA regulations, “research” is synonymous with “clinical investigation” [21 CFR 56.102(c)].

Researcher: The individual who conducts and directs the study and carries the primary responsibility for research.  The researcher is referred to as the Principle Investigator when acting as leader of a research team.

Respect for Persons: A principle enunciated in the Belmont Report stating that (1) individuals should be treated as autonomous agents, and, (2) persons with diminished autonomy are entitled to protection.

Risk: The probability of harm or injury occurring as a result of participation in a research study.

Risk-Benefit Analysis: Risk (harm) to participant vs. potential benefits; also referred to as risk-benefit assessment.

S

Secretary: In the context of the federal regulations pertaining to the protection of human subjects in research, refers to the head of a federal agency [45 CFR 46.102(a)].

Site Visit: Typically refers to a visit from a federal office to ensure the entity is complying with federal regulations.

Sponsor: An individual, company, institution, or organization taking responsibility for initiation, management and financing of a research study.  Typically refers to the entity that initiates a clinical investigation but does not actually conduct the investigation [21 CFR 50.3(e) and 56.102(j)].

Sponsor-Investigator: An individual who both initiates and actually conducts a clinical investigation [21 CFR 50.3(f) and 56.102(k)].

Subjects: See “Human Subject.”

Subpart A: Known as the "Common Rule," The DHHS codification of the Federal Policy for the Protection of Human Subjects in Research is found in Subpart A of 45 CFR Part 46.

Subpart B: Subpart B of the DHHS regulations [45 CFR Part 46] contains additional protections for pregnant women and fetuses that are involved in research, and references human in vitro fertilization research.

Subpart C: Subpart C of the DHHS regulations [45 CFR Part 46] contains additional protections for prisoners who are involved in research.

Subpart D: Subpart D of the DHHS regulations [45 CFR Part 46] contains additional protections for children who are involved in research.

Surveys: Studies designed to obtain information from human subjects through written questionnaires, telephone interviews, door-to-door canvassing, or similar procedures.

Suspension: Typically used in the context of a federal agency taking action against an institution. For example, the Office for Human Research Protections can suspend an Assurance, preventing the institution from continuing to conduct studies supported with federal funds.

T

Test Article: Any drug, biological product for human use, medical device for human use, human food additive, color additive, electronic product subject to FDA regulations under 42 USC 262, 263b-263N [21 CFR 50.3(j) and 56.102(e)].

Toxicity: An adverse effect to an organ system and/or to the participant's subjective status produced by therapy.  Toxicities are "graded" numerically, with the lowest number representing no toxicity (e.g., 0 = none) and the highest number highest representing lethal toxicity (e.g., 5 = lethal).

Tuskegee: Often used erroneously to refer to the U.S. Public Health Service Syphilis Study in Tuskegee, Alabama.

U

Unaffiliated Member:  See “Non-affiliated member”

Unanticipated Problems Involving Risks to Subjects or Others: This is a regulatory phrase which requires reporting of this event to the IRB and to the government [45 CFR 46.103(d)(5); 21 CFR 56.108(b)].

Undue Influence: This refers to a prohibition in the Common Rule that investigators not use unfair measures or influence to enroll persons in research [45 CFR 46.116].

Unexpected Adverse Event: That adverse event not described in the Package Insert, Investigator's Brochure, in published medical literature, in the protocol, or in the informed consent document.

V

Voluntary: Free of coercion, duress, or undue influence.

Vulnerable Participants/Population: Individuals/group that cannot give informed consent because of limited autonomy (e.g., children, mentally ill, prisoners), or who may be unduly  influenced to participate (e.g., students, subordinates, terminally ill).  This is a regulatory phrase which refers to a group of people who have some condition or situation that makes them more susceptible to coercion or undue influence [45 CFR 46.107(a)].

W

Waiver of Informed Consent: An action taken by the IRB permitting the investigator to pursue research involving human subjects without obtaining informed consent [45 CFR 46.116(d)].

 

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