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Accrual Goal: The proposed total number of subjects that are to be screened and/or enrolled in the study.
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. The event does not necessarily have a causal relationship with the study.
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.
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. It is 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).
Authorization: (or HIPAA authorization) occurs when an individual who is the subject of some information gives a researcher permission to use and disclose that information for research purposes. Obtaining a HIPAA Authorization is the most direct method a researcher has for using and disclosing data. Such authorization is distinct from informed consent for participation in a research study.
Autonomy: See “Respect for Persons”

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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. It is the 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.

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CBPR: See “Community Based Participatory Research”
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.
CTSA Consortium Child Health Oversight Committee (CC-CHOC): Forum for CTSA investigators and NIH scientists to identify collaborative opportunities to facilitate pediatric clinical and translational research through the CTSA program. This CTSA-level committee corresponds with the Department of Pediatrics TRI Committee at UAMS.
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. In Arkansas, “children” includes all those who have not yet reached their 18th birthday and have not been legally emancipated. Emancipation may be obtained through judicial decree or based upon certain events such as marriage or military service. Marriage or military service does not automatically emancipate an individual and Investigator’s should seek guidance per Policy 1.6 if the issue arises. (UAMS IRB)
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 Research Services Core (CRC): This program offers clinical investigators specialized research environments that provide the infrastructure necessary to conduct patient-oriented research. At UAMS, the CRC provides specialized research space and traditional services such as nursing support, dietary consultation, a metabolic kitchen, biostatistical support, informatics consultation and specialized core laboratories, as well as CRC coordinators to assist with the regulatory aspects of protocol management, recruitment of research subjects, and other needs. We also support ResearchMatch.org and REDCap database management software.
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.
Collaboration: The act of working together, especially in a joint intellectual effort.
*Collaborative Research: Continuum of shared research resources ranging from investigator teams, pooled expertise, shared capabilities, technologies, and databases, leveraging of institutional resources within and between institutions.
Common Rule: refers to regulations that govern human subject research and that have been adopted by seventeen federal agencies. The Common Rule is delineated in Title 45 of the Code of Federal Regulations Part 46 Subpart A.
*Community Based Participatory Research: "Community-based participatory research in health is a collaborative approach to research that equitably involves all partners in the research process and recognizes the unique strengths that each brings. CBPR begins with a research topic of importance to the community and has the aim of combining knowledge with action and achieving social change to improve health outcomes and eliminate health disparities" (W.K. Kellogg Foundation, Community Health Scholars Program).
Community Engagement: The process of working collaboratively with and through groups of people affiliated by geographic proximity, special interest, or similar situations to address issues affecting the well-being of those people.
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.
Continuing Review: substantive and meaningful review of ongoing research by the IRB. The IRB should decide the frequency of continuing review for each study protocol necessary to ensure the continued protection of the rights and welfare of research subjects. The IRB must review each study at least once per year and can require more frequent reviews, per UAMS IRB Policy 7.6.
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 requires that the Institutional Review Board (IRB) to 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)].
Core Facility: a centralized, shared resource that provides biomedical and behavioral investigators with access to instruments, technologies, and services as well as expert consultation.
CRC: See “Clinical Research Services Core”
CTSA: Clinical and Translational Science Award. Through a national consortium, CTSAs are improving how biomedical research is conducted across the nation. The consortium’s goals are to reduce the time it takes for laboratory discoveries to become treatments for patients and to train the next generation of clinical researchers. These awards are funded via the NIH National Center for Research Resources (NCRR). For more information go to http://www.ctsaweb.org/

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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.
De-identification: HIPAA applies only to identifiable information. If information received from an outside source is de-identified, it is no longer subject to HIPAA. CAUTION: De-identification for HIPAA purposes may not be the same as “anonymizing” data as commonly understood by researchers. See UAMS IRB Policy 13.3 for a list of the 18 elements that cannot be included in de-identified data.
DHHS:  U.S. Department of Health and Human Services.
DSMB:  See “Data and Safety Monitoring Board”

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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: UAMS requires all human subject research studies meeting, or appearing to meet, one of the exempt criteria described in 45 CFR 46 to be submitted through ARIA for review and approval by the IRB, as outlined in UAMS IRB Policy 7.3. No investigator or department on campus, other than the IRB Chair/Designee, has the authority to make the determination of exemption. All research, including that in the exempt categories, must meet at a minimum the principles outlined in the Belmont Report. The IRB Chair/Designee may require additional protections to meet these principles, including a level of informed consent appropriate to the research, or review by the full committee.
The UAMS IRB also requires review of studies in both FDA exempt categories. The FDA emergency use of a test article process can be found at UAMS IRB Policies 18.3 and 18.4. The FDA taste and food quality evaluation and consumer acceptance studies can be found at UAMS IRB Policy 7.3.
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.
Experiment: Generally, this refers to an intervention or interaction that is unproven and not yet scientifically validated.

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FDA:  See “Food and Drug Administration”, a component of DHHS.
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.

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Guardian: An individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care.
General Clinical Research Services Cores (GCRC): This program offers clinical investigators specialized research environments that provide the infrastructure necessary to conduct patient-oriented research. The NCRR no longer funds GCRC awards. Most GCRCs are now part of the CTSA of their respective institutions. Most are now known as Clinical Research Services Cores (CRCs).

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High End Instrumentation (HEI): This program provides a mechanism to acquire expensive equipment ($750,000 to $2 million) that is too costly to be purchased through the Federal Shared Instrumentation Grant (SIG) program.
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.

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IDE:  See “Investigational Device Exemption”
IEC:  See “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.  It is 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: See “Investigational New Drug Application”
Independent Ethics Committee (IEC): The equivalent of an IRB under the International Conference on Harmonization Guidelines for Good Clinical Practice.
Industry-Initiated Study: A study initiated by an industrial sponsor with little or no research aims added by a UAMS investigator. Usually these studies are conducted in multiple institutions.
Informed Consent Form:  a guide for, and written documentation of, the discussion that takes place during the informed consent process. It is NOT the consent, in and of itself. It must contain all required elements, as outlined in 45 CFR 46 and UAMS IRB Policy 15.1, and it must be approved by the IRB prior to its use.
Informed Consent Process: The ongoing process through which study personnel convey information about a study to a prospective human subject, such that the prospective human subject can understand the nature of the research and can legally, knowledgeably, and voluntarily agree to participate, or not. The informed consent process must be approved by the IRB and documented in an Informed Consent Process Note. 
Informed Consent Process Note: A separate Note to File in the subject’s research or medical record, documenting the informed consent process. The note must contain the date of subject entry into the study, the study title and PI’s name, the name of person obtaining consent, a statement that the subject had an opportunity to ask questions about the research and have those questions answered, and the signature of the person obtaining consent, as outlined in UAMS IRB Policy 15.5.
Institutional Review Board (IRB): An IRB established in accordance with and for the purposes expressed in 45CFR46 and 21CFR56.  The IRB 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 Development Award (IDeA): This program fosters health-related research and increased the competitiveness of investigators at institutions in 23 states and Puerto Rico with historically low aggregate success rates for grant awards from NIH. The two major initiatives of the IDeA program are the Centers of Biomedical Research Excellence (COBRE) and the IDeA Networks of Biomedical Research Excellence (INBRE). For more information: http://www.ncrr.nih.gov/research_infrastructure/institutional_development_award/

• Centers of Biomedical Research Excellence (COBRE): The COBRE initiative supports thematic multidisciplinary centers that strengthen institutional research capacity by expanding and developing biomedical faculty capability and enhancing research infrastructure that encompasses the full spectrum of the basic and clinical sciences.
• IDeA Networks of Biomedical Research Excellence (INBRE): The INBRE initiative establishes a multidisciplinary research network that strengthens the lead and partner institutions’ biomedical research expertise and infrastructure while providing research support to faculty and students, including those from community and tribal colleges.
• IDeANet: This initiative will broaden access to high-performance computational resources for data-intensive science applications and provide bioinformatics software tools and training to investigators across participating states.
• Lariat: This initiative to develop and implement a plan to provide a high-speed telecommunications network for biomedical researchers will enable scientists and educators in Alaska, Hawaii, Idaho, Montana, Nevada, and Wyoming to take advantage of the wealth of remote research resources and expertise available to scientists in other areas of the country.

Interdisciplinary: Combining or involving two or more academic disciplines or fields of study to work jointly from each disciplinary perspective, removing disciplinary barriers to address questions of mutual interest to participants.
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:  See “Institutional Review Board”

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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)].

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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.

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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].

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Oral Consent: Typically refers to informed consent that is obtained from a subject without use of a written informed consent document. Oral consent may only be used when an investigator has received a waiver of written documentation of consent from the IRB, prior to the enrollment of any subjects in the study.

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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)].
*Partnership: Foster membership, increase influence, meet needs, and develop a shared emotional connection among community members" (Chavis et al., 1990, p. 73); can serve as a catalyst for change and for engaging individuals and the community in health decision-making and action.
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 post-marketing 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 post-marketing 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].
PHS 398: Except for minor exceptions, Public Health Service (PHS) form #398 is used to apply for all new, competing continuation, and supplemental research and research training grant and cooperative agreement support from NIH and other agencies of the PHS.
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, it is 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: Privacy refers to a person’s control of others access to themselves or information about themselves. Privacy concerns people, whereas confidentiality concerns data.
Privacy Rule: The HIPAA Privacy Rule establishes national standards to protect individuals’ medical records and other personal health information. The HIPAA Privacy Rule identifies five distinct methods of using and disclosing information for research purposes. The researcher should be familiar with the five methods outlined in UAMS IRB Policy 13.3, and should choose the method most suited to his or her study.
Protected Health Information (PHI): Any information, whether oral or recorded in any form or medium,  about health status, provision of health care, or payment for health care that can be linked to a specific individual.
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.

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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 Electronic Data Capture (REDCap): A secure, web-based application for building and managing online databases. REDCap contains functional modules for data collection using case report forms and Web surveys, standards to support data sharing and shared libraries of researcher data collection instruments, methods to enable data exchange with clinical informatics systems, and automated data de-identification support to enable safer data sharing and analysis. For more information call the TRI at 613-TRI (2287): https://redcap.kent.edu/
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.
ResearchMatch.org: A registry of volunteers willing to learn more about research studies. Research Match’s goal is to bring together (1) people who are trying to find research studies, and (2) researchers who are looking for people to participate in their studies. Anyone can join ResearchMatch. It is a free and secure registry that has been developed by major academic institutions across the country. ResearchMatch is a Clinical and Translational Science Awards (CTSA) initiative funded by the National Center for Research Resources, part of the National Institutes of Health. For more information: researchmatch.org
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.

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Security Rule: The HIPAA Security Rule establishes national standards to protect individuals’ electronic personal health information that is created, received, used, or maintained by a covered entity. The Security Rule requires appropriate administrative, physical and technical safeguards to ensure the confidentiality, integrity, and security of electronic protected health information. 
Small Business Innovation Research (SBIR): This program supports domestic small business concerns to engage in research or research and development that has the potential for commercialization.
Shared Instrumentation Grant (SIG): This program provides a cost-effective mechanism for groups of NIH-supported investigators to obtain commercially available equipment that costs between $100,000 and $500,000.
Small Business Technology Transfer (STTR): This program supports innovative research in the United States that results in commercial products or services that benefit the public. An STTR grant requires research partners at universities and other nonprofit research institutions to have a formal collaborative relationship with the small business concern.
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.”

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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).
Translational Research: science that transforms discoveries arising from laboratory, clinical, or population studies into clinical applications to reduce disease incidence, morbidity, and mortality. Translational research occurs on a bi-directional continuum of T1 through T4 research that addresses human health questions and creates human health interventions.

• T1 research jump-starts the process of translation of bench research to the patient bedside, generally in a limited fashion. This is where basic science discoveries directly related to human health, case study/pilot clinical research, and Phase 1 and 2 clinical trials usually occur.
• T2 expands that sphere of discovery to larger patient populations in Phase 3 and 4 clinical trials, observational studies, or survey research in target populations. New discoveries can result in need for more translational research in basic sciences (T2T1) or influence T3 research (T2T3).
• T3, the practice-oriented stage of translational science, uses dissemination and implementation research to answer such questions as: Is treatment X actually being used in the community-at-large, and if not, why not? The identification of new clinical questions, barriers, and gaps in care related to treatment X is focused on at this stage.
• If T1 T3 studies reach their goals and data indicate efficacious practices or results, new policy or outcomes research is engendered in T4. Do existing laws or policies for insurance reimbursement allow equal access or implementation of treatment X to target populations? Is treatment X more effective or of equal effectiveness than other standard of care practices?
  

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Unanticipated Problems Involving Risks to Subjects or Others (UPIRTSO): Any incident, experience, or outcome that is unexpected (in terms of nature, severity, or frequency) and related (or possibly related) to participation in the research, and that suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized. See UAMS IRB Policy 10.2.
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.

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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)].

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Waiver of Authorization: A waiver of authorization is an action taken by the IRB permitting an investigator to use or disclose a subject’s identifiable health information for research without HIPAA authorization from the subject. To obtain the waiver, the researcher must provide adequate justification to the IRB. Waivers of authorization cannot be given retroactively. 
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)].
Waiver of Written Consent: A waiver of written consent is an action taken by the IRB permitting an investigator to engage in research involving human subjects without obtaining written documentation of their consent. Investigators may be asked to submit a script detailing the oral informed consent process. See UAMS IRB Policy 15.3.

Federal Organization Resources:

Agency for Healthcare Research and Quality (AHRQ):  AHRQ’s mission is to improve the quality, safety, efficiency, effectiveness, and cost-effectiveness of health care for all Americans. The Agency fulfills this mission by developing and working with the health care system to implement information that: Reduces the risk of harm from health care services by using evidence-based research and technology to promote the delivery of the best possible care, transforms the practice of health care to achieve wider access to effective services and reduce unnecessary health care costs, and improves health care outcomes by encouraging providers, consumers, and patients to use evidence-based information to make informed treatment decisions. http://www.ahrq.gov/

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

National Center for Research Resources (NCRR): The NCRR, a part of the National Institutes of Health (NIH), provides laboratory scientists and clinical researchers with the tools and training they need to understand, detect, treat, and prevent a wide range of diseases. NCRR supports all aspects of clinical and translational research, connecting researchers, patients, and communities across the nation. The NCRR provides funding for the CTSAs. http://www.ncrr.nih.gov/

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. http://www.nih.gov/

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.  It is located in the Office of the Secretary, Health and Human Services. http://www.hhs.gov/ohrp/

Office of Human Subjects Research (OHSR): Promotes and supports NIH's Intramural Research Program's (IR) 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). http://ohsr.od.nih.gov/

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 supersedes OPRR.

Practice Based Research Network (PBRN): Groups of primary care clinicians and practices working together to answer community-based health care questions and to translate research findings into practice.

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. http://www.usphs.gov/

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. http://www.primr.org/

Research Portfolio Online Reporting Tools (RePORT): Reports, data, and analysis of NIH research activities. This website provides access to a variety of reporting tools, reports, data, and analyses of NIH research activities. One of the tools available on the RePORT site is the RePORTER (RePORT Expenditures and Results) module. RePORTER is an electronic tool that allows users to search a repository of NIH-funded research projects and access publications and patents resulting from NIH funding. Replaced CRISP in December 2009. RePORTER retains all of the search capabilities of the CRISP system, while providing additional query fields, hit lists that can be sorted and downloaded to Excel, NIH funding for each project (expenditures), and the publications and patents that have acknowledged support from each project (results). RePORTER also provides links to PubMed Central, PubMed, and the US Patent & Trademark Office Patent Full Text and Image Database for more information on research results. http://report.nih.gov/index.aspx

Acronyms Top

CBPR: Community Based Participatory Research
CRC: Clinical Research Services Core
CTSA: Clinical and Translational Science Award
DHHS:  U.S. Department of Health and Human Services.
DSMB:  Data and Safety Monitoring Board.
FDA:  Food and Drug Administration, a component of DHHS.
GCRC: General Clinical Research Services Cores (now the CRC, Clinical Research Services Core)
HEI: High End Instrumentation
IDE:  Investigational Device Exemption.
IEC:  Independent Ethics Committee.
IND:  Investigational New Drug Application.
IRB:  Institutional Review Board. 
IDeA: Institutional Development Award
COBRE: Centers of Biomedical Research Excellence
INBRE: IDeA Networks of Biomedical Research Excellence
SBIR: Small Business Innovation Research
SIG: Shared Instrumentation Grant
STTR: Small Business Technology Transfer