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45 CFR §46: Title 45, Part 46 of the Code of Federal Regulations, Protection of Human Subjects. Most recently updated in June 1991 (Subpart B in 2002), these regulations govern human subject research conducted by all federal agencies. Together, this body of regulations governs the conduct of human subject research today.

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."

A

  • Abstention: An abstention is neither a "yes" nor a "no" vote and is cast when a member is not comfortable in voting either way. Any member is free to abstain at any time. An abstention counts toward quorum but does not count toward a super majority.
  • Adjuvant Therapy: Therapy provided to enhance the effect of a primary therapy; auxiliary therapy.
  • Adverse Device Effect: Any serious adverse effect on health or safety, any life-threatening problem or death caused by or associated with a device, or any other serious problem associated with a device that relates to the rights, safety, or welfare of research participants.
  • Adverse Effect: An 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).
  • Adverse Event (AE): Any experience or abnormal finding that has taken place during the course of a research project and was harmful to the subject participating in the research, or increased the risks of harm from the research, or had an unfavorable impact on the risk/benefit ratio; Any untoward or unfavorable medical occurrence in a clinical research study participant, including any abnormal sign (e.g. abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participants’ involvement in the research, whether or not considered related to participation in the research.
  • Advertisements: Flyers, letters, emails, notices, posters, radio/TV spots, newspaper ads, signs, brochures, internet postings that are used to invite potential participants into research studies.
  • Amendment: Any change to a protocol from what was previously approved during the period for which approval was given. Changes in research procedures, the informed consent process, and/or the consent/assent document cannot be initiated by the investigator without IRB review and approval, except where necessary to eliminate apparent immediate hazards to the subject.
    • Minor Amendment: Any change that does not materially increase the risks, nor materially decrease the benefits of the study, nor materially decrease scientific merit. Minor modifications include changes that are editorial or administrative, do not affect criteria for IRB approval, and fall within the list of categories of research eligible for expedited review.
    • Substantive Amendment: Any change that materially increases risks, or materially decreases benefits or scientific merit of the study. Substantive changes are those that may increase participant risk or decrease research benefits, and are not among the list of research activities eligible for expedited review. Examples of substantive amendments include changes to subject population, consent processes, or study design; or addition of new instruments.
  • Approved Device/Drug: An approved drug/device means the drug/device being studied has been cleared by the U.S. Food and Drug Administration (FDA) for marketing.
  • ARENA Applied Research Ethics National Association): A membership organization for individuals interested in ethical issues relating to medicine and research.
  • Arm: A group or subgroup of participants in a clinical trial that receives specific interventions, or no intervention, according to the study protocol. This is decided before the trial begins.
  • Assent: Agreement to participate in research obtained from an individual not competent to give legally valid informed consent (e.g., a child or cognitively impaired person). An assent form is like an informed consent form but is tailored to the status/age of the individual not competent to give consent. It is only binding in conjunction with parent/guardian consent.
  • Assent Form: A document written in language that is appropriate to the child subject's maturity and cognitive level and used as part of the assent process to:
    1. Describe the research study, including the research procedures, risks and benefits.
    2. Obtain the child's written agreement to participate in the study.
  • Assent of a Child: Assent means a child's affirmative agreement (verbal or written) to participate in a clinical investigation. Mere failure to object may not, absent affirmative agreement, be construed as assent.
  • Assurance: 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).See "Federalwide Assurance
  • Assured Institution: An institution with a Federalwide Assurance (FWA) that is approved by the DHHS Office for Human Research Protections (DHHS OHRP).
  • Audit: A systematic and independent examination of research activities and documents, to verify that the activities were conducted according to the protocol, sponsor's expectations, institutional procedures, good clinical practice (GCP), and applicable regulatory requirement(s).
  • Autonomy:  Personal capacity to consider alternatives, make choices, comprehend information, and act without undue influence or interference of others.

B

  • Baseline: The initial time point in a clinical trial that provides a basis for assessing changes in subsequent assessments or observations. At this reference point, measurable values such as physical exam, laboratory tests, and outcome assessments are recorded.
  • Belmont ReportA statement of basic ethical principles governing research involving human subjects issued by the National Commission for the Protection of Human Subjects in 1978
  • Beneficence: An ethical principle discussed in the Belmont Report that entails an obligation to protect persons from harm. The principle of beneficence can be expressed in two general rules: (1) do not harm; and (2) protect from harm by maximizing possible benefits and minimizing possible risks of harm.
  • Benefit: A benefit is a valued or desired outcome; an advantage.
  • Bias: When objectivity is impaired by personal gain or personal judgment. In clinical studies, bias is minimized by blinding and randomization.
  • Biologic: Any therapeutic serum, toxin, anti-toxin, or analogous microbial product applicable to the prevention, treatment, or cure of diseases or injuries.
  • Biological ProductA virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide), or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), used for the prevention, treatment, or cure of a disease or condition of human beings. Biological products include bacterial vaccines, allergenic extracts, gene therapy products, growth factors, cytokines, monoclonal antibodies, and recombinant DNA. Biological products may be considered drugs.
  • Blinded Study Designs:  Study designs comparing two or more interventions in which the investigators, subjects, or some combination thereof do not know group assignments.
  • Broad ConsentBroad consent involves asking participants for permission to store identifiable data and/or biospecimens for future research on a specific disease or condition, but where the nature of the future research is not yet known.

C

  • Case-Control Study: 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.
  • Case Report Form (CRF): A printed, optical, or electronic (eCRF) document designed to capture all protocol-required information for a study.
  • Case Report or Case Study: A case report is one in which three or fewer records are accessed. Case reports do not meet the definition for human subjects research and do not require oversight by the IRB if the project meets the following criteria (note: An IRB determination of NHSR is required, however):
    • Nothing was done to the patient(s) with prior research intent.
    • The case report does not contain elements of a systematic investigation (e.g. statistical methods).
    • The case report describes an interesting treatment, presentation or outcome.
    • The published article will not contain any identifiable information or authorization has been obtained.
  • CAT Scan: Abbreviation for Computerized Axial Tomography, an X-ray technique for producing images of internal bodily structures through the assistance of a computer.
  • CDC: Centers for Disease Control and Prevention; an agency within the Public Health Service, Department of Health and Human Services.
  • Cell Lines: A cell-line refers to a collection of a participant's white blood cells that are kept alive, usually stored in a freezer. Researchers are able to study these cells repeatedly for many years.
  • Certificate of Confidentiality: A document that provides additional protection of data from legal subpoena. The Certificate provides protection against compelled disclosure of identifying information or other identifying characteristics of a research participant enrolled in biomedical, behavioral, clinical, and other forms of sensitive research.
  • Children: 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.
  • Class I, II, III Devices: Classification by the Food and Drug Administration of medical devices according to potential risks or hazards.
  • Classified Research: Research sponsored by a Federal government entity that involves restrictions imposed, by agreement or otherwise, on the distribution or publication of the research findings, or results for a specified period or for an indefinite duration following completion of the research.
  • Clinical Investigation (FDA Definition): Any experiment that involves a test article and one or more human subjects and is subject to requirements for submission to the Food and Drug Administration. Clinical investigations must not be initiated unless that investigation has been reviewed and approved by an IRB. 
  • Clinical Research (NIH Definition): The NIH defines clinical research as:
    • Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, or (d) development of new technologies.
    • Epidemiologic and behavioral studies.
    • Outcomes research and health.
  • Clinical Research or Study Coordinator (CRC): An individual that handles the administrative and day-to-day responsibilities of a clinical trial and acts as a liaison for the clinical site. This person may collect the data or review it before it is entered into a study database.
  • Clinical Trial: The definition of a clinical trial according to the revised Common rule and NIH is a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. 

    The FDA definition of a clinical investigation does not encompass some studies, such as behavioral interventions and surgical procedures. The FDA regulates safety/efficacy for only some kinds of therapies and diagnostics that are related to pharmaceuticals, devices and biologics. Therefore, there are some studies that will not meet the definition of a clinical investigation according to the FDA but are still considered a clinical trial according to the revised Common Rule and the NIH.

    • Phase 1 Trial: Includes the initial introduction of an investigational new drug into humans. These studies are typically conducted with healthy volunteers, typically in a very small number of individuals (e.g. 20-80 people). 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. 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.
    • Phase 2 Trial: Includes 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.
    • Phase 3 Trial: Involves the administration of a new drug to a larger number of patients (e.g. several hundred - several thousand) 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 and adequate basis for physician labeling. An NIH-defined Phase III clinical trial is a broadly based prospective Phase III clinical investigation, usually involving several hundred or more human subjects, for the purpose of evaluating an experimental intervention in comparison with a standard or controlled intervention or comparing two or more existing treatments.   Often the aim of such investigation is to provide evidence leading to a scientific basis for consideration of a change in health policy or standard of care. The definition includes pharmacologic, non-pharmacologic, and behavioral interventions given for disease prevention, prophylaxis, diagnosis, or therapy. Community trials and other population-based intervention trials are also included.  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 4 Trial: Studies conducted after a drug has been approved by FDA, to delineate 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.  These studies are designed to monitor effectiveness of the approved intervention in the general population and to collect information about any adverse effects associated with widespread use.
  • Code of Federal Regulations (CFR): The Code of Federal Regulations is an annual codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government. The CFR is divided into 50 titles representing broad areas subject to Federal regulation. Each Title is divided into chapters that are assigned to agencies issuing regulations pertaining to that broad subject area. Each chapter is divided into parts and each part is then divided into sections -- the basic unit of the CFR. The purpose of the CFR is to present the official and complete text of agency regulations in one organized publication and to provide a comprehensive and convenient reference for all those who may need to know the text of general and permanent Federal regulations (National Archives).
  • Coded Data or Specimens: Replacement of identifiable private information with a number, letter, symbol, or combination thereof (i.e., identification code) when a key to decipher the code is maintained thus linking the identification code (and coded data or specimen) to private information.
  • Coercion: The act of using force or threats, whether actual, implied, perceived or indirect, to encourage an individual to participate in a research study.
  • Cognitively Impaired: Having either a psychiatric disorder (e.g., psychosis, neurosis, personality or behavior disorders, or dementia) or a developmental disorder (e.g., mental retardation) that affects cognitive or emotional functions to the extent that capacity for judgment and reasoning is significantly diminished. Others, including persons under the influence of or dependent on drugs or alcohol, those suffering from degenerative diseases affecting the brain, terminally ill patients, and persons with severely disabling physical handicaps, may also be compromised in their ability to make decisions in their best interests.
  • Cohort: A group of subjects initially identified as having one or more characteristics in common who are followed over time. In social science research, this term may refer to any group of persons who are born at about the same time and share common historical or cultural experiences.
  • Collaborating Investigator: An individual who is not otherwise an employee or agent of an assured institution and who is conducting collaborative research activities with a University or affiliate investigator. Collaborating investigators may be either:
    1. "Collaborating Institutional Investigators" who are acting as an employee or agent of a non-assured institution that does not routinely conduct human subjects research or
    2. "Collaborating Independent Investigators" who are not acting as an agent or employee of any institution.
  • Collaborative IRB Training Initiative (CITI): An internet-based set of educational modules on the protection of human participants in research. It is sponsored by a consortium of IRB professionals and researchers from universities and medical schools across the country and is administered by the University of Miami (see: www.citiprogram.org).
  • Common Rule: The Common Rule, which governs research with human subjects conducted or supported by 15 federal departments and agencies including EPA, establishes a comprehensive framework for the review and conduct of proposed human research to ensure that it will be performed ethically. EPA's codification of the Common Rule. The central requirements of the Common Rule are:
    • That people who participate as subjects in covered research are selected equitably and give their fully informed, fully voluntary written consent; and
    • That proposed research be reviewed by an independent oversight group referred to as an Institutional Review Board (IRB), and approved only if risks to subjects have been minimized and are reasonable in relation to anticipated benefits, if any, to the subjects, and the importance of the knowledge that may reasonably be expected to result.
  • Compassionate Use of Investigational Devices: The FDA defines "compassionate use" as the use of a test article on a human subject with a serious disease or condition for which there is no acceptable treatment available. FDA and IRB approval for compassionate use is required. The IRB will not approve an application for compassionate use until it has been approved by the FDA.
  • Community Based Clinical Trial (CBCT): A clinical trial conducted primarily through primary-care physicians rather than academic research facilities.
  • Community Member: (aka "Non-Affiliated Member") A member of an Institutional Review Board who has no ties to an institution, its staff, or faculty. This individual is usually from the local community (e.g., minister, business person, attorney, teacher, homemaker, etc.). 
  • Company Protocol: A document used to define and manage the trial usually sent by the Industry Sponsor or the lead site if it is a multi-center study. Not all studies will include a protocol, but studies that involve investigational drugs; investigational devices will always have this document. The protocol describes the scientific rationale, objective(s), design, methodology, statistical considerations and organization of the planned trial. The protocol contains a precise study plan to assure safety and health of the trail subjects and to provide an exact template for trial conduct by investigators. This allows data to be combined across all investigators/sites. The format and content of clinical trial protocols sponsored by pharmaceutical, biotechnology, or medical device companies in the United States, European Union, or Japan have been standardized to follow Good Clinical Practice guidance. 
  • Compassionate Use: A method of providing experimental therapeutics prior to the final FDA approval. This allows treatment for sick individuals who have no other options. Often, case-by-case approval must be obtained from the FDA for "compassionate use" of a drug, therapy or device. For more information about compassionate use, visit the FDA website
  • Compensation: Payment for participation in research.
  • Competence (i.e. Capacity to Consent): Denotes 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.
  • Compliance: Adherence, in this case, to federal regulations, state laws, institutional policies and sponsor requirements.
  • Concomitant Medication: Prescription and over-the-counter drugs and supplements a study participant has taken along with the study intervention. This information may be collected as a history item as well as during the study. Some studies may collect only those medications that may interact with the study or intervention or that may exclude an individual from participating in a study.
  • Confidentiality: The maintenance of information in keeping with the investigator's agreement with the research participant regarding how the participant's involvement in research and their identifiable private information will be handled, managed, disseminated and protected from release or access by others. Confidentiality becomes part of the agreement between the researcher and the research participant, and is described in the consent documents and is detailed during the consent process.
  • Conflict of Interest (COI): The real or apparent interference of one person's interests with the interests of another person, where potential bias may occur due to prior or existing personal or professional relationships.  A conflict of interest occurs when individuals involved with the conduct, reporting, oversight, or review of research also have financial or other interests, from which they can benefit, depending on the results of the research.
  • Consent Document(s): Commonly referred to as the "ICF" or "Informed Consent Form." These are the documents presented to a subject or parent guardian prior to beginning a study. Most studies will have this document submitted with the proposal, unless requesting a Waiver (see below). The IRB has provided a template on the web site for investigators to prepare their documents.
    • Adult Informed Consent: This is required when subjects are 18 years and older. This should be written to the subject using appropriate language ("you").
    • Parental Permission Document:This is required when subjects are 17 years and younger. This should be written to the parent/guardian using appropriate language ("your child").
    • Assent Document: Assent is an agreement by an individual not competent to give legally valid informed consent (e.g., a child aged 7+ or cognitively-impaired person) to participate in research. This is required for children enrolled in studies that are 7-17 years of age. If the board deems appropriate, this can be requested for younger children.
  • Continuing Review: Periodic review of a research study by an IRB to evaluate whether risks to participants remain reasonable in relation to potential benefits and to verify the study continues to meet regulatory and institutional requirements. Continuing review shall be conducted at intervals appropriate to the degree of risk but not less than once per year. (45 CFR 46.109(e); 21 CFR 56.109(f))
  • Contract: An agreement that a specific research activity will be performed under the direction of an entity providing funds. Research performed under a contract is more closely controlled by the entity than research performed under a grant.
  • Contraindicated: Disadvantageous, perhaps dangerous; a treatment that should not be used in certain individuals or conditions due to risks (e.g., a drug may be contraindicated for pregnant women and persons with high blood pressure).
  • Control Group: The group of individuals in a clinical trial assigned to a comparison intervention.
  • Controlled Trial: A type of clinical trial in which observations made during the trial are compared to a standard (called the control). The control may be observations from a group of participants in the same trial or observations from outside the trial (for example, from an earlier trial, called a historical control).
  • Controls, Historical: Control subjects (followed at some time in the past or for whom data are available through records) who are used for comparison with subjects being treated concurrently. The study is considered historically controlled when the present condition of subjects is compared with their own condition on a prior regimen or treatment.
  • Convenience Sample: Convenience sampling selects a particular group of people based on aspects of the potential participants' situation which renders them more easily accessed by the investigator or more likely to complete research participation without regard for the representativeness of the sample. Convenience sampling does not come close to sampling all of a population or a representative sample of a population. Convenience sampling may unfairly expose a population to research related risks.
  • Coordinating Center: A group organized to coordinate the planning and operational aspects of a multi-center clinical trial. CCs may also be referred to as Data Coordinating Centers (DCCs) or Data Management Centers (DMCs).
  • Crossover Design: A type of clinical trial in which each subject experiences, at different times, both the experimental and control therapy. For example, half of the subjects might be randomly assigned first to the control group and then to the experimental intervention, while the other half would have the sequence reversed.
  • Custom Device: A device that
    • In order to comply with the order of an individual physician or dentist, deviates from devices generally available, or from an applicable performance standard or premarket approval requirement;
    • Is not generally available to, or generally used by, other physicians or dentists;
    • Is not generally available in finished form for purchase or for dispensing upon prescription;
    • Is not offered for commercial distribution through labeling or advertising; and
    • Is intended for use by an individual patient named in the order of a physician or dentist, and is to be made in a specific form for that patient, or is intended to meet the special needs of the physician or dentist in the course of professional practice.
  • Covered Entity: Health care providers who conduct certain financial and administrative transactions electronically, such as billing and fund transfers; also, all health plans and health care clearinghouses (45 CFR 160.103). Covered Entities must comply with HIPAA regulations. Weill Cornell Medicine's Covered Entity includes Weill Cornell Medical College and New York Presbyterian. 
  • Crossover Design: Describes a clinical trial in which groups of participants receive two or more interventions in a particular order. For example, a two-by-two crossover design involves two groups of participants. One group receives drug A during the initial phase of the trial, followed by drug B during a later phase. The other group receives drug B during the initial phase, followed by drug A during a later phase. So during the study, participants "cross over" to the other drug. All participants receive drug A and drug B at some point during the study, but in a different order, depending on the group to which they are assigned.
  • Cytogenetic Testing: Cytogenetics is the study of the structure of chromosome material. When cytogenetic testing is used, typically study doctors want to know about changes in the chromosomes seen by microscope with either G-banding (conventional staining of the chromosomes) and/or fluorescent in situ hybridization (FISH). This assists study doctors in identifying chromosomal abnormalities that might affect the development of a particular condition and its treatment. In some forms of cancer, especially hematological malignancies, cytogenetics can determine which chromosomal translocations are present in the malignant cells, facilitating diagnosis and susceptibility to treatment.

D

  • Data and Safety Monitoring Board (DSMB): A committee of scientists, physicians, statisticians, and others that collects and analyzes data during the course of a clinical trial to monitor for adverse effects and other trends (such as an indication that one treatment is significantly better than another, particularly when one arm of the trial involves a placebo control) that would warrant modification or termination of the trial or notification of subjects about new information that might affect their willingness to continue in the trial.
  • Data Analysis: The process of applying statistical techniques to describe, summarize, and compare data to extract useful information and facilitate conclusions.
  • Data Management: The processes of handling the data collected during a clinical trial from development of the study forms/CRFs through the database locking process and transmission to statistician for final analysis.
  • Data Management Plan (DMP): A plan that documents the processes for handling the flow of data from collection through analysis. Software and hardware systems along with quality control and validation of these systems, as relevant are described.
  • Data Safety Monitoring Board (DSMB): An independent committee that collects and analyzes data during the course of a clinical trial to monitor for adverse effects and other trends that would warrant changes or early closure of the trial.
  • Data Safety Monitoring Plan: Data and Safety Monitoring means the process to ensure and maintain the scientific integrity of human subject research and to protect the safety of human subjects, a system for appropriate oversight and monitoring to ensure the safety of participants and the validity of the data. The section of a protocol that describes the steps to identify physical, social, or psychological occurrences that may result from participation in the research study and explains in detail how such occurrences will be handled and reported. A DSMP describes the timing, tools and/or method(s) for monitoring and evaluation, procedures for treatment or resolution (including circumstances which would result in halting or terminating research), procedures for and timing of reports to oversight bodies, and description of oversight bodies involved with the study (e.g. FDA, IRB, or Data and Safety Monitoring Board). A study does not need to have a Data and Safety Monitoring Board to have a DSMP.
  • Data Transfer Agreement/Data Use Agreement: A Data Use Agreement (DUA) is a contractual document used for the transfer of data that has been developed , where the data is nonpublic or is otherwise subject to some restrictions on its use. Often this data is a necessary component of a research project and it may or may not be human subject data from a clinical trial, or limited data set information as defined in HIPAA. Universities will want to ensure that DUA terms protect confidentiality when necessary, but permit appropriate publication and sharing of research results in accordance with institution policies, applicable laws and regulations, and federal requirements. DUAs are similar to confidentiality agreements.
  • Data Use Agreement: An agreement between the provider and the intended recipient of research data set that establishes the ways in which the information may be used and how it will be protected.
  • Debriefing: Giving subjects previously undisclosed information about the research project following completion of their participation in research. (Note that this usage, which occurs within the behavioral sciences, departs from standard English, in which debriefing is obtaining rather than imparting information).
  • Deception in Research: Deception is the intentional misleading of subjects or the withholding of full information about the nature of a research experiment or procedure. Misleading or omitted information might include the purpose of the research, the role of the researcher, or what procedures in the study are actually experimental.
  • Declaration of Helsinki: A code of ethics for clinical research approved by the World Medical Association in 1964 and widely adopted by medical associations in various countries. It has been revised several times, most recently in October, 2000.
  • Deferral: Submissions to the IRB that: (1) require substantial revisions (e.g., specific wording cannot be provided by the convened IRB); or (2) prompt questions that cannot be answered within the context of the IRB meeting, will be deferred for further review by the convened IRB at a later date.
  • De-identified PHI: Health information from which a covered entity has removed all 18 HIPAA identifiers as long as the covered entity has no actual knowledge that the remaining information could be used alone or in combination with other information to identify the individual to whom the information applies.
  • Demonstration Project: Implementation of a method, technology, policy or idea to assess feasibility prior to full implementation. For example, proof of concept studies or the initiation of a benefit or service program or modification of such program for the purpose of assessing its ability to improve the provision of government programs.
  • Design: A research design is a plan or analytical approach for answering research questions. Some examples of research designs are experimental, correlational, observational, and single case. The selection of a particular study design depends on the information sought.
  • Device: An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is
    • recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them;
    • intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals; or
    • intended to affect the structure or any function of the body of man or other animals and which does not achieve its primary intended purposes through chemical action or metabolism within or on the body.
  • Device Determination, Non-significant Risk Device: An investigational medical device that does not present significant risk to the patient.
  • Device Determination, Significant Risk Device: An investigational medical device that presents a potential for serious risk to the health, safety, or welfare of the subject.
  • Devices, CLASS I, II, III Devices: Classification by the Food and Drug Administration of medical devices according to potential risks or hazards.
  • Diagnostic Trials: Trials that are conducted to find better diagnostic tests/procedures for identifying a particular disease or condition. Diagnostic trials enroll people who have signs or symptoms of a disease or condition being studied.
  • Dietary Supplement: A product meant for ingestion that contains a "dietary ingredient" intended to add further nutritional value to (supplement) the diet. A "dietary ingredient" may be one, or any combination, of the following substances:
    • vitamin,
    • mineral,
    • herb or other botanical,
    • amino acid,
    • dietary substance for use by people to supplement the diet by increasing the total dietary intake
    • concentrate, metabolite, constituent, or extract

    NOTE: A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with Dietary Supplement Health and Education Act it is not a drug solely because the label or the labeling contains such a statement.

  • Disclosure: The release, transfer, provision of access to or divulgence in any other manner of PHI outside the entity holding the information.
  • Double Blind Masking: A type of masking in which two or more parties involved with the clinical trial do not know which participants have been assigned which interventions. Typically, this includes the investigator and participant.
  • Drug: Any article (other than food)
    • recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them;
    • intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals;
    • intended to affect the structure or any function of the body of man or other animals; or
    • intended for use as a component of any article as specified above.

E

  • Educational Practices: Curriculum-related interventions or classroom activities. For Special Education these include activities that correspond to the Individualized Educational Program for a student with an identified disability.
  • Educational Setting: An environment in which students learn. Educational settings include preschool, elementary, secondary, and higher educational facilities and programs; and alternative settings where educational services or activities are provided such as home instruction, electronic or web-based courses and schools, and after-school programs when these involve tutoring or homework help.
  • Efficacy: Indication that the clinical trial intervention produces a desired therapeutic effect on the disease or condition under investigation.
  • Eligibility Criteria: List of criteria guiding enrollment of participants into a study. The criteria describe both inclusionary and exclusionary factors, (e.g. inclusion criterion - participants must be between 55 and 85 years old; exclusion criterion – must not take drug X three month prior to the study).
  • Emancipated Minor: A minor who is at least 16 years of age, who is married or living apart from his or her parents or legal guardian, and who is a resident of the county, and has petitioned the court of that county for a decree of emancipation; and the court determines that the petition should be granted and enters a decree of emancipation for the petitioner.
  • Emergency Use: The FDA defines “emergency use” as the use of a test article on a human subject in a life-threatening situation in which no standard acceptable treatment is available, and in which there is not sufficient time to obtain IRB approval [21CFR 56.102 (d)].
  • Empirical: Based on experimental data; not theory.
  • Employee: For purposes of this policy, employee refers to a person employed by WCM and its affiliates
  • Endpoint: A target outcome of a trial. Endpoints are chosen because they are measurable
  • Engagement of Institutions (in Non-Exempt Human Subjects Research): An institution is considered engaged in a particular human subjects research project when its employees or agents for the purposes of a non-exempt research project obtain:
    1. Data about the subjects of the research through intervention or interaction with them;
    2. Identifiable private information about the subjects of the research; or
    3. The informed consent of human subjects for the research.

    An institution is also considered engaged when the institution receives a direct federal award to conduct human subject research, even when all activities involving human subjects are carried out by a subcontractor.

    An individual is considered engaged in human research when he/she for the purposes of the non-exempt research project, obtains:

    1. Data about the subjects of the research through intervention or interaction with them
    2. Identifiable private information about the subjects of the research; or
    3. The informed consent of human subjects for the research.
  • Equitable: The fair or just selection of study subjects (principle of justice) to assure that the benefits and burdens of research are equally distributed.
  • Ethnographic/Fieldwork/Anthropology Research: Ethnography is the study of people and culture. Ethnographic research involves observation of a person or group studied in their own environment, often for long periods of time.
  • Exculpatory: Pertaining to that which relieves of a responsibility, obligation, or hardship; clearing from accusation or blame.
  • Exempt Research: Exempt research is Human Subjects Research that meets one of the minimal risk categories in the federal regulations.
  • Expanded Access: A process regulated by the Food and Drug Administration (FDA) that allows manufacturers to provide investigational new drugs, devices, or test articles to patients with serious diseases or conditions who cannot participate in a clinical trial.
  • Expedited Review: Review of proposed research by the IRB Chairperson or a designated voting member or group of voting members rather than by the entire IRB. Federal rules permit expedited review for certain kinds of research involving no more than minimal risk and for minor changes in approved research.
  • Experimental Drug: A drug that has an Investigational New Drug (IND) application filed with the FDA, but has yet to be licensed.
  • Expired Study: When a continuing review of the research does not occur prior to the end of the approval period specified by the IRB, IRB approval expires automatically. The study expires on the date specified on the approval letter and the informed consent document. No activities can occur on the expiration date or after.

F

  • Family Member: For purposes of this policy, any one of the following legally competent persons: spouse; parents; grandparents; children (including adopted children); brothers, sisters, and spouses of brothers and sisters; and any individual related by blood or affinity whose close association with the subject is the equivalent of a family relationship. [21 CFE 50.3(m)]
  • Federal-Wide Assurance (FWA): A standing agreement on file with the Office for Human Research Protections that describes in detail the procedures it will use to protect the rights and welfare of the human subjects.
  • FERPA: (Family Education Rights and Privacy Act) was enacted in 1974. It is a set of regulations that applies to those institutions that receive funding from the Department of Education. FERPA was written specifically for students and guarantees them the right to inspect and review their education records, the right to seek to amend education records, and the right to have some control over the disclosure of information from those education records. Departments may not release non-directory or personally identifiable information about a student to a third party (parents included) without the student's written authorization.
  • Fetus: A developing human from two months after conception to birth. If the delivered or expelled fetus is viable, it is designated an infant [45 CFR 46.203(c)]. The term "embryo" is usually used for earlier phases of development.
  • Food and Drug Administration (FDA): An agency within the U.S. Department of Health and Human Services (DHHS) responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, nation’s food supply, cosmetics, and products that emit radiation.
  • Final Project Reports: Once a study is completed, this form is submitted to close out the study.
  • Full Baord Review: Review of proposed or continuing research (primarily greater than minimal risk research) by a convened IRB meeting, at which a majority of the voting membership is present.

G

  • Gene Therapy: The treatment of genetic disease accomplished by altering the genetic structure of either somatic (non-reproductive) or germline (reproductive) cells.
  • Generalizable Knowledge: Information obtained from projects or investigations that are designed to draw general conclusions, to transfer or extrapolate results to a broader population or situation than those from which the information was initially derived, or to establish or enhance scientific evidence about a topic of interest.
  • Good Clinical Practice (GCP): A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial participants are protected.
  • Grandfathered: To exempt an existing or in progress study from new regulations.
  • Grant: Financial support provided for a research study. Fund givers typically do not exercise strict control over the grants they have awarded.
  • Guardian: An individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care when general medical care includes participation in research. It also means an individual who is authorized to consent on behalf of a child to participate in research.

H

  • Healthcare Provider: A person considered to be engaged in the patient's medical care.
  • Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule: The first comprehensive Federal protection for the privacy of personal health information. The Privacy Rule regulates the way certain health care groups, organizations, or businesses, called covered entities under the Rule, handle the individually identifiable health information known as protected health information (PHI).

HIPAA Terminology:

      • Authorization: Permission from individuals to use or disclose their Protected Health Information; generally required for research involving PHI. Certain statements are required; similar to but in addition to the Common Rule's informed consent; can be added to a consent form. (45 CFR 164.508)
      • Covered Entity: Defined as health care providers who conduct certain financial and administrative transactions electronically, such as billing and fund transfers; also, all health plans and health care clearinghouses. Covered Entities must comply with HIPAA. (45 CFR 160.103).
      • Disclosure: The release, transfer, provision of access to, or divulging in any other manner of information outside the Covered Entity holding the information (45 CFR 164.501).
      • Protected Health Information (PHI): Information about the past, present, or future physical or mental health of an individual that identifies or could be used to identify the individual and is created or received by a Covered Entity. (45 CFR 160.301164.501); information about the provision of health care and payment for health care is included; some educational and employment records are excluded.)
      • Humanitarian Device Exemption: An HDE is a pre-market approval application submitted to the FDA (see also Investigational Device Exemption, Medical Device, Humanitarian Use Device [PDF]).
      • Humanitarian Use Device (HUD): A Humanitarian Use Device (HUD) is a device that is intended to benefit patients by treating or diagnosing a disease that affects fewer than 4,000 individuals in the United States per year. To be considered for HUD status, a device sponsor must complete a humanitarian device exemption (HDE) application with the FDA. An approved HDE application authorizes the applicant to market the HUD. The labeling for the HUD must state that the device is an HUD and that the effectiveness of the device has not been demonstrated.
      • Human Participants: Individuals whose physiologic or behavioral characteristics and responses are the object of study in a research project. Under the federal regulations, human participants are defined as: living individual(s) about whom an Investigator conducting research obtains: (1) data through intervention or interaction with the individual; or (2) identifiable private information. NOTE: FDA's regulations define human subject as an individual and do not use the adjective "living."
      • Human Participants Research: This term applies to federally regulated research in which human participants (see definition above), their data, tissue, genetic material or other is investigated in a systematic fashion. It includes clinical trials, retrospective studies (subject to IRB oversight or exempt from continuing IRB oversight), outcome studies, surveys, etc.
  • Healthy Volunteer: A healthy volunteer is a person with no known significant health problems who participates in clinical research to test a new drug, device, or intervention.
  • HIPAA Authorization: Authorization is defined under HIPAA as the granting of rights to access protected health information (defined below) (PHI). Authorization is required by HIPAA for disclosures or uses of PHI other than for treatment and related procedures and operations. Importantly, treatment cannot be conditioned on granting of an authorization. An authorization is a specific, detailed document requesting patient-subject permission for the use of covered PHI.
  • Human In-Vitro Fertilization: Fertilization involving human sperm and ova that occurs outside the human body (e.g. a test tube).
  • Human Research Protection Program (HRPP): The Human Research Protection Program (HRPP) is the total of all departments and individuals responsible for the protection of human research subjects.  At WCM, the HRPP consists not only of the Office of Research Integrity and the IRB, but also the entire research community.  The HRPP is headed by the Institutional Official (IO).
  • Human Subjects Research: According to IRB policy, research involving human subjects (participants) is defined as any one of the following:
    • Human subjects research subject to FDA regulation: Activities are human research subject to FDA regulations when they meet the FDA definition of "clinical investigations" and involve a "subject" as defined in FDA regulation.
      • Under FDA regulation activities are "clinical investigations" when they involve:
        • Use of a drug other than the use of an approved drug in the course of medical practice
        • Use of a medical device other than the use of an approved medical device in the course of medical practice
        • Gather data that will be submitted to or held for inspection by FDA in support of a FDA marketing permit for a food, including a dietary supplement that bears a nutrient content claim or a health claim, an infant formula, a food or color additive, a drug for human use, a medical device for human use, a biological product for human use, or an electronic product.
      • In the above criteria "approved" means "approved by the FDA for marketing."
      • Under FDA regulations, individuals are considered "subjects" when they become a participant in research, either as a recipient of the test article or as a control. If the research involves a medical device, individuals are considered "subjects" when they participate in an investigation, either as an individual on whom or on whose specimen an investigational device is used or as a control.
    • Human subjects research subject to DHHS regulation: Activities are human subject research subject to DHHS regulations when they meet the DHHS definition of "research and involve a "subject" as defined in DHHS regulations.
      • Under DHHS regulations activities are "research" when they are a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
      • Under DHHS regulations "subjects" means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.
        • Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.
        • Interaction included communication or interpersonal contact between investigator and subject.
        • Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.
    • Research that does not meet the definition of research involving human subjects must be determined by the IRB staff, not an individual investigator. Investigators must complete and submit an IRB new study application with any applicable documents.
  • Human In Vitro Fertilization: Any fertilization involving human sperm and ova that occurs outside the human body.
  • Human Subject: A patient or healthy individual who is or becomes a participant in research, either as a recipient of the intervention or as a control.
  • Humanitarian Device Exemption: FDA approval of a Humanitarian Device Exemption (HDE) application is necessary in order to allow the marketed use of a Humanitarian Use Device (HUD). The HDE is similar to a Pre-Market Approval (PMA), but because a HUD is exempt from the effectiveness requirements of a PMA, an HDE application is not required to contain the results of scientifically valid clinical investigations demonstrating that the device is effective for its intended purpose. The HDE must contain sufficient information for FDA to determine that the probable benefit to health outweighs the risk of injury or illness, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment.
  • Humanitarian Use Device: A medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in not more than 8,000 individuals in the United States per year. HUDs can only be used in a facility after an IRB has approved their use in that facility, except in certain emergencies.

I

  • Identifiable Biospecimen: An identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen. [45 CFR 46.102(e)(6)]
  • Identifiable Private Information: Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information. [45 CFR 46.102(e)(5)]
  • Immediate Family: Spouse, domestic partner or dependent children.
  • Immediately Life-Threatening Disease: A stage of a disease in which there is a reasonable likelihood that death will occur within a matter of months or in which premature death is likely without early treatment.
  • Incidental Finding: 
    • Anticipated: Results that are outside the original purpose for which a test or procedure was conducted, but that are known to be associated with the test or procedure: Study is designed to discover A, but learns B, a result known to be associated with the test or procedure in use. B is an anticipated incidental finding.
      • Example: Researchers use the Patient Health Questionnaire (PHQ) assess for depression and learn a participant is having suicidal thoughts.
    • Unanticipated: Results that are outside the original purpose for which a test or procedure was conducted and that could not have been anticipated given the current state of scientific knowledge: Study is designed to discover A, but learns C, a unexpected result.  C is an unanticipated incidental finding.
      • Example: Genetic testing identifies a health risk based on a newly discovered genetic association (not known at the time the study was designed).
  • Inclusion/Exclusion Criteria: The pre-determined conditions of a clinical trial that allow or exclude participation. These criteria are factors such as age, gender, type and stage of a disease, previous treatment history, and/or other medical conditions.
  • Incomplete Disclosure: Investigators withhold information from participants related to the specific purpose, nature, or other key aspect of the research.
  • IND Safety Reports: Sponsor notifications to FDA and all participating investigators (i.e., all investigators to whom the sponsor is providing a drug under its or investigators' INDs) which may include:
    1. Serious and unexpected suspected adverse reaction;
    2. A single occurrence of an event that is uncommon and known to be strongly associated with drug exposure;
    3. One or more occurrences of an event that is not commonly associated with drug exposure, but is otherwise uncommon in the population exposed to the drug;
    4. An aggregate analysis of specific events observed in a clinical trial that indicates those events occur more frequently in the drug treatment group than in a concurrent or historical control group;
    5. Findings from other studies that suggest a significant risk in humans exposed to the drug;
    6. Findings from animal or in vitro testing that suggest a significant risk in humans exposed to the drug; or
    7. A clinically important increase in the rate of a serious suspected adverse reaction over that listed in the protocol or investigator brochure.
  • Individually Identifiable: The identity of the research participant is or may readily be, ascertained by the investigator or associated with the information.
  • Individually Identifiable to a Private Person (as defined by the justice department): Information which either is labelled by name or other personal identifiers; or by virtue of sample size or other factors, be reasonably interpreted as referring to a particular private person.
  • Informed Consent: A process by which a participant or legal guardian voluntarily confirms his or her willingness to participate in a particular research project, after having been informed of all aspects of the research that are relevant to the subject's decision to participate. Informed consent is documented by means of a written, signed, and dated informed consent form approved by an IRB, unless such documentation is waived by the IRB (45 CFR 46).
    • A person's voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research or to undergo a diagnostic, therapeutic, or preventive procedure. In giving informed consent, subjects may not waive or appear to waive any of their legal rights, or release or appear to release the investigator, the sponsor, the institution or agents thereof from liability for negligence [Federal Policy §116; 21 CFR 50.20 and 50.25] (OHRP).
  • Informed Consent Form/Document: A document that describes the rights of a study participant and provides details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document.
  • Institution: Institution means any public or private entity, or department or agency (including federal, state and other agencies).
  • Institution Employees/Agents: Individuals who:
    1. Act on behalf of the institution.
    2. Exercise institutional authority or responsibility.
    3. Perform institutionally designated activities. "Employees and agents" can include staff, students, contractors, and volunteers, among others, regardless of whether the individual is receiving compensation.
  • Institutional Conflict of Interest: Situations in which the University's beneficial relationship with corporate entities may place it in conflict with its responsibilities as a public institution of higher education. The conflict may involve equity interest in companies, receipt of significant financial donations from external entities, certain licensing situations and Board and other leadership positions held by University faculty or administrators.
  • Institutional Official: A senior official named in the FWA who has the authority to commit the entire organization, as well as all of the components listed in the FWA, to a legally binding agreement. The Institutional Official (IO) also has the authority to assure compliance of the organization and all of its components to the Terms of the FWA. At the University, the IO is the Vice President of Research.
  • Institutional Review Board (IRB)/Independent Ethics Committee (IEC): An independent body constituted of medical, scientific, and nonscientific members whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trials, protocols and amendments, and of the methods and material to be used to obtaining and documenting informed consent of the trial participant.
  • Interaction: An interaction may be communication or interpersonal contact between the investigator (or research team) and the living individual. Examples include interviews, questionnaires, surveys, observations, manipulations of subject behavior, diet, or environment, physical measurements, specimen collection (e.g. blood tissue), and administration of experimental drugs or devices. Projects which collect information about policies, practices or procedures - even if the person who provided that information is identified - do not constitute human subject research.
  • International Studies:  Procedures and policies that apply to research taking place outside the U.S. often differ from those set forth in the U.S. federal policies. U.S. federally funded research activities in a foreign country may be approved only if the ethical protections are equivalent to those in the U.S. This is also true for FDA approval of drugs/devices/biologics tested outside the United States.
  • International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH): ICH guidance was published in the Federal Register on May 9, 1997 (62 FR 25692).
  • Intervention: A procedure or treatment such as a drug, nutritional supplement, gene transfer, vaccine, behavior or device modification that is performed for clinical research purposes (45 CFR 46.102(f)). Interventions can also include noninvasive approaches such as surveys, education, and interviews.
  • Investigational Brochure (IB): In drug development, the Investigator's Brochure is a comprehensive document summarizing the body of information about an investigational product or "study drug" obtained during a drug trial. The IB is a document of critical importance throughout the drug development process and is updated with new information as it becomes available. The purpose of the IB is to compile data relevant to studies of the study drug in human subjects gathered during preclinical and other clinical trials.
    • An IB is intended to provide the investigator with insights necessary for management of study conduct and study subjects throughout a clinical trial.  An IB may introduce key aspects and safety measures of a clinical trial protocol, such as: dose (of the study drug), frequency of dosing interval, methods of administration, and safety monitoring procedures.
    • An IB contains a "Summary of Data and Guidance for the Investigator" section, of which the overall aim is to "provide the investigator with a clear understanding of the possible risks and adverse reactions, and of the specific tests, observations, and precautions that may be needed for a clinical trial. This understanding should be based on the available physical, chemical, pharmaceutical, pharmacological, toxicological, and clinical information on the investigational product(s). Guidance should also be provided to the clinical investigator on the recognition and treatment of possible overdose and adverse drug reactions that is based on previous human experience and on the pharmacology of the investigational product".
    • The sponsor is responsible for keeping the information in the IB up-to-date. The IB should be reviewed annually and must be updated when any new and important information becomes available, such as when a drug has received marketing approval and can be prescribed for use commercially.
  • Investigational Device: According to the Food and Drug Administration (FDA), an investigational device is a device, including a transitional device, that is the object of a [clinical] investigation involving one or more subjects to determine the safety or effectiveness of the device (21 CFR 812.3). Investigational use also includes clinical evaluation of certain modifications or new intended uses of legally marketed devices.
    • Also, see IDE Definitions and Acronyms for more definitions related to this term.
    • The use of an investigational device in human subjects requires approval by the IRB and may also require approval from the FDA.
  • Investigational Device Exemption (IDE): Exemptions from certain regulations found in the Medical Device Amendments that allow shipment of unapproved devices for use in clinical investigations [21 CFR 812.20].
  • Investigational New Drug: According to the Food and Drug Administration (FDA), investigational new drug means a new drug or biological drug that is used in a clinical investigation. The term also includes a biological product that is used in vitro for diagnostic purposes. The terms "investigational drug" and "investigational new drug" are deemed to be synonymous. (21 CFR 312.3)
    • The use of an investigational drug (IND) in human subjects requires approval by the FDA and the IRB.
    • An IND number is generally required for a drug (including a drug with marketing authorization) if it is intended to:
      • Support a new indication for use, establish safety or efficacy of the drug, support a change in the approved route of administration (including method of assembly) or dosage level;
      • Support a change in the approved patient population (e.g. pediatric vs. adults) or a population at greater/increased risk (e.g. immunocompromised, elderly, etc.);
      • Support a change in the promotion/ advertising/ labeling/ packaging of an approved drug.
    • An IND number may also be required for investigations that attempt to gain further information about an approved use. The study sponsor and/or investigator cannot represent (in a promotional context) that the drug is safe and effective for the purposes in which it is under investigation.
  • Investigational New Drug Application (IND): An IND is a request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans. Such authorization must be secured prior to interstate shipment and administration of any new drug or biological product that is not the subject of an approved New Drug Application or Biologics/Product License Application (21 CFR 312).
  • Investigational New Drug (IND) or Device (IDE): A drug or device permitted by FDA to be tested in humans but not yet determined to be safe and effective for a particular use in the general population and not yet licensed for marketing (Also, see Investigational Device Exemption (IDE)).
  • Investigator-Initiated Research: Research that is initiated and conducted by an individual rather than a sponsor/pharmaceutical company. The investigator has the same responsibilities that a sponsor would have.
  • Investigator's Brochure: A compilation of the clinical and non-clinical data on the investigational product(s) that is relevant to the study of the investigational product(s) in human subjects.
  • In Vitro: Literally, "in glass" or "test tube;" used to refer to processes that are carried out outside the living body, usually in the laboratory, as distinguished from in vivo.
  • In Vivo: Literally, "in the living body;" processes, such as the absorption of a drug by the human body, carried out in the living body rather than in a laboratory (in vitro).
  • IRB of Record: An Institutional Review Board (IRB) designated as the Reviewing IRB for human subject research as specified in an IRB Authorization Agreement, Cooperative Agreement, Memorandum of Understanding, or other contract between the University and an external institution. The IRB of Record assumes all of the IRB responsibilities for human research activities subject to the agreement.
  • IRB Records: IRB records include but are not limited to: minutes from IRB meetings, proposals reviewed, amendments, investigator brochures, and supplemental information including recruitment materials, consent forms, continuing reviews, correspondence, and IRB membership.

J

  • Justice: An ethical principle discussed in the Belmont Report requiring fairness in the equitable distribution of burdens and benefits within the study population.

K

  • Key Information Section: A section of the informed consent document that presents a concise and focused presentation of key information of the study to assist prospective subjects in understanding reasons to enroll in a protocol or not.
    • The regulatory preamble lists 5 items that would generally be considered key information (but are not explicitly required as such by the regulations):
      • that consent is being sought for research and that participation is voluntary; 
      • the purposes of the research, the expected duration of the prospective subject’s participation, and the procedures to be followed in the research
      • the reasonably foreseeable risks or discomforts to the prospective subject;
      • the benefits to the prospective subject or to others that may reasonably be expected from the research; and 
      • appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the prospective subject. 
  • Key Personnel:Key Personnel are the individuals who have access to Protected Health Information (PHI) and generate data either through direct interactions with subjects or through access to their medical records.  Key Personnel and their study roles must be listed on an IRB submission.

L

  • Legally Authorized Representative (LAR):A person authorized either by statute or by court appointment to make decisions on behalf of another person. In human subject research, an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research.  There are several considerations that must be addressed when the inclusion of an LAR is proposed, such as, whether periodic re-consenting is warranted, and whether the probability of benefit is greater than the probability of harm.
  • Life-Threatening: 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.
  • Limited Capacity:A person who is able to make independently some but not all of the decisions necessary for the person's own care and the management of the person's property; and the person is not a minor.
  • Limited Data Set:A limited data set could include the following (potentially identifying) information:
    • Admission, discharge, and service dates;
    • Dates of birth and, if applicable, death;
    • Age (including age 90 or over); and
    • Five-digit zip code or any other geographic subdivision, such as state, county, city, precinct and their equivalent geocodes (except street addresses).
    Covered entities must condition the disclosure of the limited data set on execution of a "data use agreement," which
    • establishes the permitted uses and disclosures of such information by the recipient, consistent with the purposes of research, public health, or health care operations;
    • limits who can use or receive the data; and
    • requires the recipient to agree not to re-identify the data or contact the individuals.
    In addition, the data use agreement must contain adequate assurances that the recipient will use appropriate physical, technical and administrative safeguards to prevent use or disclosure of the limited data set other than as permitted by HIPAA and the data use agreement, or as required by law.
  • Longitudinal Study: A study designed to follow subjects forward through time.

M

  • Manual of Procedures (MOP): A set of procedures describing study conduct. A MOP is developed to facilitate consistency in protocol implementation and data collection across study participants and clinical sites.
  • Masking/Blinding: A procedure in which the investigator administering the assessments and intervention as well as the participants in a clinical trial are kept unaware of the treatment assignment(s). Single blinding usually refers to the study participant(s) being unaware, and double blinding usually refers to the study participant(s) and any of the following being unaware of the treatment assignment(s): investigator(s), monitor, and data analyst(s).
  • Material Transfer Agreement: A Material Transfer Agreement (MTA) is a document that is used by scientists and their institutions to transfer materials to other scientists and institutions. MTAs provided by outside organizations may contain clauses that are not consistent with the University of Utah policies and procedures and/or federal law. Signing one of these agreements could severely impede a scientist's ability to carry out his or her research or to publish in a timely fashion. It is important that all MTAs are evaluated and signed by an authorized TVC representative. The Technology Venture Commercialization Office handles and processes these agreements.
  • Medical Device: According to the FDA, a device is: "An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
    • recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
    • intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
    • intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it's primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes." (See: Is The Product A Medical Device?).
  • Metabolism (of a drug): The manner in which a drug is acted upon (taken up, converted to other substances, and excreted) by various organs of the body.
  • Minimal Risk: Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests (45 CFR 46.102(i)). For example, the risk of drawing a small amount of blood from a healthy individual for research purposes is no greater than the risk of doing so as part of routine physical examination.  This is not interpreted to include the inherent risks certain categories of human subjects face in their everyday lives. For example, the risks imposed in research focused on a special population should not be evaluated against the inherent risks encountered in their work environment (e.g., emergency responder, pilot, soldier in a combat zone).
    In addition, the IRB generally subscribes to the recommendations related to 45 CFR 46.404 from SACHRP regarding research involving children.
  • Minimal Risk Prisoner Research: Minimal risk, in regard to prisoners, is defined as: 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. Note: "Harms," when referring to prisoners, are specifically described as physical or psychological and that the standard minimal risk for prisoners who are research subjects is not based on the daily life of a healthy prisoner, but refers to a healthy person as an absolute standard based on the daily lives of healthy non-incarcerated individuals.
  • Minor: Any person who is 18 years of age; or less than 19 years of age if guardianship is continued until the person reaches the age of 19 years pursuant to NRS 159.191.
  • Modification: See Amendment
  • Monitoring: A systematic, ongoing process to evaluate or oversee the conduct of research procedures.

N

  • Neonate: A newborn.
  • New Drug Application (NDA): An application submitted by the manufacturer of a drug to the FDA, after the clinical trial has been completed, for a license to market the drug for a specified indication.
  • NIH: National Institutes of Health: a federal agency within the Public Health Service, DHHS, comprising 21 institutes and centers. It is responsible for carrying out and supporting biomedical and behavioral research.
  • Non-Affiliated Member: Member of an Institutional Review Board who has no ties to the parent institution, its staff, or faculty. This individual is usually from the local community (e.g., minister, business person, attorney, teacher, homemaker).
  • Non-Compliance: Any action or activity associated with the conduct or oversight of research involving human subjects that fails to comply with the research plan as approved by a designated IRB, or federal regulations or institutional policies governing such research. Noncompliance may range from minor to serious, be unintentional or willful, and may occur once or several times.

Noncompliance includes deviations to the protocol made in the interest of a single participant such as to coordinate study visits. Noncompliance may result from the action of a participant, investigator or staff and may or may not impact the rights and welfare of research participants or others, or the integrity of the study. Complaints or reports of noncompliance from someone other than the research investigator are handled as allegations of noncompliance until such time that the allegation is validated or found to be invalid and dismissed.

Minor Noncompliance

Any behavior, action or omission in the conduct or oversight of research involving human subjects that deviates from the approved research plan, federal regulations or institutional policies but because of its nature, the research project or the subject population,

  • Does not place, or have the potential to place, participants and others at greater risk than previously anticipated;
  • Does not have a substantive effect on the value of the data collected; and
  • Does not result from willful or knowing misconduct on the part of investigators or study staff.

Examples of minor noncompliance may include, when such noncompliance does not create additional risks to subjects:

  1. Changing study personnel without notifying the IRB;
  2. Shortening the duration between planned study visits;
  3. Implementing minor wording changes in study questionnaires without first obtaining IRB approval; or
  4. Routine lab missed at scheduled visit and re-drawn later.

Serious Noncompliance

Any behavior, action or omission in the conduct or oversight of human research that has been determined to:

  1. Affect the rights and welfare of participants and others;
  2. Increase risks to participants and others, decrease potential benefits or otherwise unfavorably alter the risk/benefit ratio;
  3. Compromise the integrity or validity of the research; or
  4. Result from the willful or knowing misconduct on the part of investigators or study staff.

Examples include, but are not limited to the following:

  1. Failing to obtain Informed consent before enrolling a participant in a research study;
  2. Conducting non-exempt research that requires direct interaction or interventions with human subjects without first obtaining IRB approval; 
  3. Enrolling subjects who fail to meet the inclusion or exclusion criteria in a protocol that involves greater than minimal risk and that in the opinion of the IRB Chair, designee, or convened Committee, places the participant(s) at greater risk; or
  4. Failing to report adverse events, unanticipated problems, or substantive changes to the proposed protocol to the IRB in accordance with IRB policy.

Continuing Noncompliance: A pattern of noncompliance that, in the judgment of the IRB Chair, designee or convened Board,

  1. Indicates a lack of understanding or disregard for the regulations or institutional requirements that protect the rights and welfare of participants and others,
  2. Compromises the scientific integrity of a study such that important conclusions can no longer be reached,
  3. Suggests a likelihood that noncompliance will continue without intervention, or
  4. Involves repeated or frequent instances of minor noncompliance.

Continuing noncompliance may also include failure to respond to a request from the IRB to resolve an episode of noncompliance or a pattern of minor noncompliance

  • Non-Inferiority Design: A non-inferiority trial compares a test treatment to a control treatment of established effectiveness and seeks to show that the test treatment is not materially worse than or inferior to the control treatment. A non-inferiority trial seeks to show that any difference between the two treatments is small enough to allow a conclusion that the test treatment has at least some effect or, in many cases, an effect that is not significantly less than the active control. A non-inferiority trial may proceed under 21 CFR 50.24 if it meets the requirements of the regulation. 
    For a non-inferiority trial to be informative, there would need to be clear data about the effectiveness of the control treatment (to make the non-inferiority study interpretable) and about known safety or other problems associated with the control treatment. Non-inferiority trials are generally used in situations where a placebo-controlled trial would be unethical and where there are no data to suggest the new treatment would be more effective than the standard treatment.
  • Non-Significant Risk Device: An investigational medical device that does not present significant risk to the research subject (e.g., tongue depressor, or swab).
  • Non-Therapeutic Research: Research that has no likelihood or intent of producing a diagnostic, preventive, or therapeutic benefit to the current subjects, although it may benefit subjects with a similar condition in the future.
  • Non-Viable Fetus: An expelled or delivered fetus which, although it is living, cannot possibly survive to the point of sustaining life independently, even with the support of available medical therapy [45 CFR 46.203 (d) and (e)]. Although it may be presumed that an expelled or delivered fetus is nonviable at a gestational age less than 20 weeks and weight less than 500 grams [Federal Register 40 (August 8, 1975): 33552], a specific determination as to viability must be made by a physician in each instance. (See also: Viable Infant.)
  • Null Hypothesis: The proposition, to be tested statistically, that the experimental intervention has "no effect," meaning that the treatment and control groups will not differ as a result of the intervention. Investigators usually hope that the data will demonstrate some effect from the intervention, thereby allowing the investigator to reject the null hypothesis.
  • Nuremberg Code: A code of research ethics developed during the trials of Nazi war criminals following World War II and widely adopted as a standard during the 1950s and 1960s for protecting human subjects.

O

  • Observational Study: A clinical study in which participants identified as belonging to study groups are assessed for biomedical or health outcomes. Participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to specific interventions (as in an interventional study).
  • Off-Label Use:  A drug used for conditions other than those approved by the FDA.
  • Office for Human Research Protections (OHRP): A federal government agency within the Department of Health and Human Services (DHHS) charged with the protection of human subjects participating in government funded research. It issues assurances and oversees compliance of regulatory guidelines by research institutions.
  • Open-Label (Open-Label Trial): Describes a clinical trial in which masking is not used. This means that all parties involved with the trial know which participants have been assigned which interventions.
  • Orphan Drugs: An FDA category of medication used to treat rare diseases and conditions.

P

  • Parallel Design: Describes a clinical trial in which two or more groups of participants receive different interventions. For example, a two-arm parallel design involves two groups of participants. One group receives drug A, and the other group receives drug B. So during the trial, participants in one group receive drug A "in parallel" to participants in the other group who receive drug B.
  • Parent: A natural or adoptive parent whose parental rights over the child have not been terminated by the Courts
  • Parental Permission: The agreement of parent(s) or guardian to the participation of their child or ward in research [45 CFR 46.402(c)].
  • Peer Review:  Experts with the same scholarly background as the person submitting a project, who review research for scientific merit, participant safety, and ethical acceptability.
  • Permission: The agreement of parents to the participation of their child in research.
  • Person: Any individual, partnership, corporation, association, public or private organization or governmental entity, or combination thereof.
  • Pharmacokinetics (PK): The process (in a living organism) of absorption, distribution, metabolism, and excretion of a drug or vaccine.
  • Pharmacology: The scientific discipline that studies the action of drugs on living systems (animals or human beings).
  • Phase 1, Phase 2, Phase 3, Phase 4 Clinical Trial: See "Clinical Trial".
  • Phenotype: The physical manifestation of a gene function.
  • Placebo: A placebo is an inactive pill, liquid, powder, or other intervention that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the treatment's effectiveness.
  • Placebo Control Trial: A method of investigation in which an inactive substance/treatment (the placebo) is given to one group of participants, while the test article is given to another group. The results obtained in the two groups are then compared to see if the investigational treatment is more effective in treating the condition.
  • Preclinical: Refers to the testing of experimental drugs in the test tube or in animals - the testing that occurs before human trials.
  • Pregnancy: For purposes of this policy, the period of time from implantation until delivery.
  • Pre-Market Approval: The FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices (See http://www.fda.gov/cdrh/devadvice/3132.html#class_3 for Class III device information).
  • Prevention Trials: Refers to trials that find improved ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vaccines, vitamins, minerals, or lifestyle interventions.
  • Primary Data Collection: Primary data collection involves direct contact with, or observation of, one or more people for the purpose of collecting data from or about them.
  • Principal Investigator (PI): The person who is responsible for the scientific and technical direction of the entire clinical study (for example, for all sites of a multisite study).
  • Prisoners: An individual involuntarily confined in a penal institution, including persons: (1) sentenced under a criminal or civil statue; (2) detained pending arraignment, trial, or sentencing; and (3) detained in other facilities (e.g., for drug detoxification or treatment of alcoholism) under statutes or commitment procedures providing such alternatives to criminal prosecution or incarceration in a penal institution. The definition of "minimal risk" for research involving prisoners differs somewhat from that given for non-institutionalized adults.
  • Privacy: Control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others.
  • Private Information: 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 that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public.
  • Proband: The person whose case serves as the stimulus for the study of other members of the family to identify the possible genetic factors involved in a given disease, condition, or characteristic.
  • Prophylactic: Preventive or protective; a drug, vaccine, regimen, or device designed to prevent, or provide protection against, a given disease or disorder.
  • Prospective Studies: Studies designed to observe outcomes or events that occur subsequent to the identification of the group of subjects to be studied. Prospective studies need not involve manipulation or intervention but may be purely observational or involve only the collection of data.
  • Protected Health Information (PHI): Individually identifiable health information that is covered under HIPAA consisting of the following:
    • Names;
    • Geographic subdivisions smaller than a state;
    • All elements of dates except year (including birth, admission and discharge dates; date of death; and individuals over 89 years old);
    • The following categories of numbers: telephone and fax, social security, medical record, health plan beneficiary, account, certificate and license numbers;
    • Electronic mail (e-mail) and internet protocol (IP) addresses;
    • Internet universal resource locators (URLs);
    • Vehicle and device identifiers and serial numbers;
    • Biometric identifiers (e.g., finger and voice prints);
    • Full-face photographic or comparable images; and
    • Any other unique identifying number, characteristic or code.
  • Protocol: A document that describes the objective(s), design, methodology, statistical consideration, and organization of a trial.
    • Protocol Amendments: A written description of a change(s) to or formal clarification of a protocol.
    • Protocol Deviations: Failure to conduct a study as described in the protocol. The failure may be accidental or due to negligence and in either case, the protocol deviation should be documented. This also includes failure to comply with federal laws and regulations, the institution's commitments and policies, and standards of professional conduct and practice. Examples of noncompliance include:
      • failure to obtain/maintain approval for research,
      • failure to obtain informed consent when required,
      • failure to file adverse event reports,
      • performance of an unapproved study procedure,
      • performance of research at an unapproved site,
      • failure to file protocol modifications and
      • failure to adhere to an approved protocol.
    • Protocol Deviation Report: Internal document created as part of the ongoing quality control process summarizing compliance with the protocol and listing protocol deviations and/or violations.
    • Protocol Review and Monitoring Committee (PRMC): The Protocol Review and Monitoring Committee (PRMC) was formed in 1993 to comply with National Cancer Institute guidelines in establishing a scientific review and monitoring system of cancer studies - it is a mechanism for quality assurance. The PRMC membership includes faculty, statisticians, pharmacy, imaging, patient advocate, research nurse and other ad hoc reviewers from various disciplines within the Health Sciences. The PRMC reviews cancer-related protocols for scientific merit and progress, including participant accrual. It also prioritizes cancer protocols that may compete for the same patient population. Its function is complementary to that of the Institutional Review Board, which focuses on the protection of human subjects in research. If a study is designed to involve cancer patients, it must receive PRMC approval before it can be IRB approved. If a study includes cancer patients by default (as part of a broader patient population) and not by study design, it doesn't need PRMC review.
    • Protected Health Information (PHI): Information about the past, present, or future physical or mental health of an individual that identifies or could be used to identify the individual and is created or received by a Covered Entity. (45 CFR 160.301, 164.501; information about the provision of health care and payment for health care is included; some educational and employment records are excluded.)
    • Protocol Summary: This document is completed by the PI and includes a summary of the protocol or can be the study plan for the entire study. Protocol summaries are required for all studies submitted to the IRB.
    • Public Disclosure:
      • Before a planned emergency research protocol begins, the dissemination of information in the communities in which the study will take place and from which the subjects will be drawn sufficient to allow a reasonable assumption that the communities are aware that the study will be conducted, and its risks and benefits; and
      • After the study has been conducted, the dissemination of information to the communities in which the study was conducted and to scientific researchers sufficient to describe the study's demographic characteristics and the study's results.

    Q

    • Quality Assurance/Quality Improvement (QA/QI): These are activities designed to improve the quality of a process or assess its overall function. While such activities do not satisfy the definition of “research” under 45 CFR 46.102(d), which is “…a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge…”, the determination of such can only be made by the IRB. If the IRB makes the determination that your QA/QI project qualifies for Exempt or Non Human Subjects Research, the HHS regulations for the protection of human subjects do not apply, and is not under the purview of the IRB (no review or approval necessary).

      The clinical, practical, or administrative uses for such performance measurements and reporting could include, for example, helping the public make more informed choices regarding health care providers by communicating data regarding physician-specific surgical recovery data or infection rates. Other practical or administrative uses of such data might be to enable insurance companies or health maintenance organizations to make higher performing sites preferred providers, or to allow other third parties to create incentives rewarding better performance.
    • Quorum: A majority of voting members (50% + 1) who must be present for a convened IRB  meeting to proceed. Must be maintained and documented for all votes.

    R

    • Radiopaque Contrast Agents: 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.
    • Randomization: The process of assigning clinical trial participants to treatment or control groups using an element of chance (e.g. like flipping a coin) to determine the assignments in order to reduce bias.
    • Recombinant DNA Technology: "The ability to chop up DNA, the stuff of which genes are made, and move the pieces, [which] permits the direct examination of the human genome," and the identification of the genetic components of a wide variety of disorders [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.
    • Record: A record is any information preserved in a fixed medium, whether on paper, electronically or otherwise.

      IRB protocol records include protocol submissions, approved protocol documents (e.g., protocol application, recruitment materials, assessment instruments, and consent forms); all relevant correspondence between the IRB and investigators; and documentation of IRB review (e.g., reviewer checklists, file notes).

    • Recruitment/Recruitment Materials: Recruitment is the process by which potential subjects are informed about a study. Recruitment materials, such as fliers, email messages, newspaper ads, and phone calls, must be accurate, non-coercive, and must not emphasize monetary compensation. These materials must be approved by the IRB.
    • Recruitment Plan:  The plan that outlines how individuals will be recruited for the study and how the study will reach the recruitment goal.
    • Related Events: These are events that are possibly, probably, or definitely caused by the research procedures or related to research participation.
    • Reliance Agreement: An IRB Reliance Agreement is a written document between Einstein and an external site or individual.  It allows the Einstein IRB to extend its IRB oversight to the site/individual for the conduct of a specific study.
    • REM: 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.
    • Remission: A period in which the signs and symptoms of a disease are diminished or in abeyance. The term "remission" is used when one cannot say with confidence that the disease has been cured.
    • Remuneration: Payment for participation in research. (NOTE: It is wise to confine use of the term "compensation" to payment or provision of care for research-related injuries.)
    • Research: A clinical investigation or a systematic investigation, including research and development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
      • DHHS Definition: A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge [45 CFR 46.102(l)]. The following activities are deemed not to be research:
        1. Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
        2. Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
        3. Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
        4. Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.
        • FDA Definition: Any experiment that involves a test article and one or more human subjects and that is either subject to requirements for prior submission to the FDA under section 505(i) or 520(g) of the Act, or is not subject to requirements for prior submission to the FDA under these sections of the Act, but the results of which are intended to be submitted later to, or held for inspection by, the FDA as part of an application for research or marketing permit. The terms "research," "clinical research," "clinical study," "study," and "clinical investigations" are deemed to be synonymous for purposes of this part (21 CFR 50.3(c) and 21 CFR 56.102(c)
    • Research Affiliate: An institution with whom the University has entered into an IRB Authorization Agreement (IAA), allowing the institution to designate a University IRB as IRB of record on the institution's FWA or vice versa.
    • Research Involving a Human Being as an Experimental Subject: According to the Department of Defense Directive 3216.02 section E2.1.3., this means 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. 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 does not include: (1) 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. (2) Authorized health and medical activities as part of the reasonable practice of medicine or other health professions. (3) 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.
    • Respect for Persons: An ethical principle discussed in the Belmont Report requiring that individual autonomy be respected and persons with diminished autonomy be protected.
    • Retention Plan: The plan that details the methods in which the study will use in order to retain study participation in the clinical trial.
    • Retrospective Study: Research conducted by reviewing records from the past (e.g., birth and death certificates, medical records, school records, or employment records) or by obtaining information about past events elicited through interviews or surveys. Case control studies are an example of this type of research.
    • Revisions: Changes requested by the IRB following review by expedited procedures or at convened meetings.
      • Minor Revisions: Changes requested by the IRB that are editorial or proscriptive (i.e., investigators are given specific text or parameters for addressing the changes); or confirm IRB assumptions. Minor revisions may be re-reviewed by expedited procedures.
      • Substantive Revisions: Changes requested by a convened IRB that relate directly to the criteria for IRB approval and require clarification or explanation from the researcher. Substantive revisions must be re-reviewed at a convened IRB meeting.
    • Risk Determinations: The probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study. Both the probability and magnitude of possible harm may vary from minimal to significant. Federal regulations define only "minimal risk." (See also: Minimal Risk.)  These can include:
      • Moderate Risk: The subject will undergo procedures that will increase their risks above those normally encountered in daily life. Equivalent term is "more than minimal risk." These can include, but are not limited to: clinical drug trials, device trials, genetic studies, and risks that include insurability and employability.
      • Minimal Risk: The subject will undergo procedures that do not appear to increase the risks above those normally encountered in daily life. These can include but are not limited to studies that involve survey, questionnaire, interview, medical records review, observation of behaviors, drawing a small amount of blood from a healthy individual, etc.
      • Exempt: These studies are not usually reviewed by board members, but are reviewed by the chairman. These have been determined to fit certain federal regulations as exempt from IRB review.
    • Risk/Benefit Ratio: Comparing the potential benefits to the risks of participating in a research study.

    S

    • PDF icon Safe Harbor De-Identification [PDF]: Potential identifiers include obvious ones like name and social security number, and also:
      • All geographic subdivisions smaller than a state, including street address, city, county, precinct, zip code, and their equivalent geocodes, except for the initial three digits of a zip code if, according to the current publicly available data from the Bureau of the Census: the geographic unit formed by combining all zip codes with the same three initial digits contains more than 20,000 people; and [t]he initial three digits of a zip code for all such geographic units containing 20,000 or fewer people is changed to 000.
      • All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, date of death; and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older;
      • Voice and fax telephone numbers;
      • Electronic mail addresses;
      • Medical record numbers, health plan beneficiary numbers, or other health plan account numbers;
      • Certificate/license numbers;
      • Vehicle identifiers and serial numbers, including license plate numbers;
      • Device identifiers and serial numbers
      • Internet Protocol (IP) address numbers and Universal Resource Locators (URLs);
      • Biometric identifiers, including finger and voice prints;
      • Full face photographic images and any comparable images; and
      • Any other unique identifying number, characteristic, or code.
      Under HIPAA's "safe harbor" standard, information is considered de-identified if all of the above have been removed, and there is no reasonable basis to believe that the remaining information could be used to identify a person.
    • Scientific Merit: An assessment of whether or not a study represents good science. For example a study with scientific merit addresses an area of importance to the discipline, utilizes established scientific principles, exhibits alignment within the study, offers congruence among research questions and study design, and is likely to contribute to scientific knowledge.
    • Screening Log: An essential document that records all individuals who entered the screening process. The screening log demonstrates the investigator’s attempt to enroll a representative sample of participants.
    • Screening Process: A process designed to determine individual’s eligibility for participation in a clinical research study.
    • Secondary Data: Secondary data is data collected by someone other than the user. Common sources of secondary data for social science include censuses, surveys, organizational records and data collected through qualitative methodologies or qualitative research. Primary data, by contrast, are collected by the investigator conducting the research.
    • Sensitive Information at Risk of Subpoena: Any information which could be of interest to the court in civil, criminal or other judicial proceedings. Most commonly this includes the use of alcohol, illegal drugs or addictive products and illegal behavior. Other examples which may in some instances be of interest to the court include information regarding HIV, AIDS, and other STDs; sexual practices or preferences; the participant's psychological state or mental health; information that can be linked to a participant's financial standing, employability or reputation within the community or that might lead to social disgrace or prejudice; genetic information or identifiable biological samples and corresponding data that may be used to demonstrate predisposition to disease or disputes in paternity; or information regarding behavioral interventions.
    • Serious Adverse Event (SAE): Any adverse event that:
      • Results in death
      • Is life threatening, or places the participant at immediate risk of death from the event as it occurred
      • Requires or prolongs hospitalization
      • Causes persistent or significant disability or incapacity
      • Results in congenital anomalies or birth defects
      Is another condition which investigators judge to represent significant hazards
    • Serious Disease or Condition: A disease or condition associated with persistent or recurrent morbidity that has substantial impact on day-to-day functioning. Generally the definition does not include short-lived and self-limiting morbidity. The morbidity needn't be irreversible to constitute a serious disease or condition. Whether a disease or condition is serious is a matter of clinical judgment, based on its impact on such factors as survival, day-to-day functioning, or the likelihood that the disease, if left untreated, will progress from a less severe condition to a more serious one.
    • Severely Debilitating: 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.
    • Sham Comparator Arm: A group of participants that receives a procedure or device that is made to be indistinguishable from the actual procedure or device being studied but does not contain active processes or components.
    • Side Effect: Any undesired action or effect of a drug or treatment. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental drugs must be evaluated for both immediate and long-term side effects.
    • Significant Risk (SR) Device: A device that presents a potential for serious risk to the health, safety, or welfare of a subject and:
      1. Is intended as an implant, or
      2. Is used in supporting or sustaining human life, or
      3. Is of substantial importance in diagnosing, curing, mitigating or treating a disease, or otherwise prevents impairment of human health, or
      4. Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.
    • Single-Blind/Blind Study: A study in which one party, either the investigator or participant, is unaware of what medication the participant is taking.
    • Source Document: Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, participant diaries, recorded data from automated instruments, x-rays, etc.) that are used in a clinical trial.
    • Special Guardian: A guardian of a person of limited capacity, including, without limitation, such a guardian who is appointed because a person of limited capacity has voluntarily petitioned for the appointment and the court has determined that the person has the requisite capacity to make such a petition.
    • Sponsor: A person, federal agency, corporation, or other entity that provides funds for a research project.
    • Sponsor-Investigator: An individual who both initiates and actually conducts - alone or with others - a clinical investigation. Corporations, agencies, or other institutions do not qualify as Sponsor-Investigators.
    • Standard Operating Procedures (SOPs): Detailed written instructions to achieve uniformity of the performance of a specific function across studies and patients at an individual site.
    • Standard Treatment/Standard of Care: A treatment or regimen in wide use and considered to be effective in the treatment of a specific disease or condition. (Often used as comparator for a new drug, device, biologic or treatment).
    • Stopping Rules: Established safety criteria that would either pause or halt a study due to reasons including but not limited to futility or risk(s) to the participants.
    • Stratification: Separation of a study cohort into subgroups or strata according to specific characteristics such as age, gender, etc., so that factors which might affect the outcome of the study, can be taken into account.
    • Study Arm: Any of the treatment groups in a randomized trial. Most randomized trials have two “arms” but some have three or more.
    • Surrogate Consent: Consent for an individual to participate in research given by an appropriate surrogate (e.g., next of kin including spouse, parent, child, sibling) when an individual is assessed as not capable of providing fully informed and legally effective consent.
    • Survey: A means to obtain information from respondents through written questionnaires, telephone interviews, door-to-door canvassing, or similar procedures.
    • Suspension/Termination of IRB Approval: A determination by the IRB Chair, a designated IRB member, or the convened IRB to temporarily interrupt some or all previously-approved research activities. The suspended activities could include, but not be limited to, recruiting and enrolling new subjects. Suspended studies remain open and require continuing review.NOTE: Suspensions of IRB approval apply to interruptions in research activities due to concerns about the safety, rights, or welfare of human research subjects or others. They do not include interruptions in human research resulting solely from the expiration of the IRB approval period.
    • Systematic Investigation: Systematic Investigation is typically a predetermined method for studying a specific topic, answering a specific question(s), testing a specific hypothesis(es), or developing theory. Systematic investigations include observational studies, interview or survey studies, group comparison studies, test development, and interventional research.

    T

    • Termination of IRB Approval: A determination by the convened IRB to permanently halt some or all previously approved research activities including, but not limited to, enrollment of new subjects. NOTE: Terminations of IRB approval apply to a cessation of research projects or activities due to concerns about the safety, rights, or welfare of human research subjects or others. They do not include interruptions in human research resulting solely from the expiration of the IRB approval period.

    • Test Article: Any drug (including a biological product for human use), medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under or under sections 351 and 354-360F of the Public Health Service Act (42 USC 262 and 263b-263n).
    • Therapeutic Misconception: Potential research participants who are also patients believe that a clinical trial proposed by their health care provider will provide a therapeutic benefit to them, even after being told that there is no assured benefit.
    • Tissue/Specimen Banking: Specimen collection banks, whether they are described as "banks" or not, are many and varied. They cover the spectrum from individual clinicians' research specimen collections, (often gathered with no specific project in mind) to institutional "Tissue Banks" (such as cancer center shared resource banks) to multi-center, industry-sponsored drug trials which usually collect at least some blood or tissue for unspecified future research.
    • Toxicity: A detrimental effect produced by a drug or condition.
    • Tracked Changes: In word processing, track changes is an editing command that is commonly used when you create an original document and make changes and want to keep track of the changes that are made to that original document. It is also a useful tool for collaborating on a document, as it allows multiple users to make revisions without losing the context of the original document.Changes to text and formatting are noted in a number of different ways, depending on the word processing software you use. Tracking changes allows the IRB staff and board members to clearly see what changes, modifications, updates, and additions have been made to study documents. For a tutorial on how to track changes in a document, please go to the A-Z Index page
    • Transitional Device: Transitional device: a device subject to section 520(l) of the FD&C Act and which FDA previously regulated as a new drug or an antibiotic drug before May 28, 1976.
    • Translation Certification Letter [DOC]: Certifies the authenticity of the translation of a translated Consent Document. A reference template for the Translation letter can be found on the IRB website.

    U

    • Unanticipated Event: Problems, risks or events that occur during the conduct of the research, but were not expected and therefore are not cited in the written protocol, the consent form(s) or the Investigator's Brochure. Unanticipated events also include problems, risks or adverse events that were expected but occur with greater severity or frequency than originally anticipated.
    • Unanticipated Problem (UP):Unanticipated problems are defined as any incident, experience or outcome that occurs during the course of a study that meets all of the following criteria:
      • Unforeseen (not expected by the researcher or the research participant) given the research procedures and the subject population being studied.
      • Related or probably related to participation in the research or if the event or problem probably or definitely affects the safety, rights and welfare of current participants; and
      • 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.
    • Undue Influence: The inappropriate use of prestige, wealth, ability or position to directly or indirectly affect the potential participants' decision to participate.
    • Unmasking/Unblinding: A procedure in which one or more parties to the trial are made aware of the treatment assignment(s).

    V

    • Viable Infant: 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, HHS, 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.)
    • Voluntary: Free of coercion, duress, or undue inducement. Used in the research context to refer to a subject's willingness to participate (or continue to participate) in a research activity.
    • Vulnerable Populations: Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, and patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.

    W

    • Waiver of Authorization: In some situations, the IRB can waive the requirement that research subjects sign an Authorization Form. To qualify for a Waiver of Authorization, the research use of the health information should not represent more than a minimal risk to privacy, and the researcher should indicate that the research could not be done without the requested health information, that it would not be practical to obtain signed authorizations from the research subjects, and that the specific elements of health information that are requested are not more than the minimum necessary to accomplish the goals of the study.
      1. That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or
      2. That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.
    • Waiver of Informed Consent: Occasionally there are reasons to waive written consent or to alter the requirements of consent. Only the IRB can make the determination to waive some (written) or all (written and verbal) consent requirements. In order to qualify for a Waiver of Consent, the following conditions should be met: 1) that the research pose no more than minimal risk to subjects; 2) no adverse effects as a result of the waiver or alteration; 3) without the waiver or alteration the research in question could not be carried out; and 4) information will be provided after participation is completed, if appropriate.
    • Wards of State: A ward means a child who is placed in the legal custody of the State or other agency, institution, or entity, consistent with applicable Federal, State, or local law. The term “ward of State” may be used interchangeably with “ward” in this document. For inclusion in a study, a number of additional considerations must be made.
    • Washout Period: The action or process of progressively reducing the concentration of a substance (i.e. drug) in a subject. Washout periods are used in some drug trials to prevent medications the subject is already taking from interacting with the test drug. Under the Placebo Guidelines, board reviewers must ensure that the proposed placebo exposure (and any corresponding washout periods) is of a specified duration such that evidence supports the exposure as no more than minimal risk. These are reviewed by the IRB on a case-by-case basis.