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Glossary

  • Abuse-Liable
    Pharmacological substances that have the potential for creating abusive dependency. Abuse-liable substances can include both illicit drugs (e.g., heroine) and licit drugs (e.g., methamphetamines).

    Adjuvant Therapy
    Therapy provided to enhance the effect of an primary therapy; auxiliary therapy.

    Adverse Effect (from OHRP IRB Guidebook)
    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 Drug Experience (Life-threatening, Serious, Unexpected) 21 CFR 312.12

    Adverse Experience (Life-threatening, Serious, Unexpected) 21 CFR 600.80

    Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA)
    Alcohol, Drug Abuse, and Mental Health Administration; reorganized in October 1992 as the Substance Abuse and Mental Health Services Administration (SAMHSA). ADAMHA included the National Institute of Mental Health (NIMH), the National Institute on Alcohol Abuse and Alcoholism (NIAAA), the National Institute on Drug Abuse (NIDA), the Office for Substance Abuse Prevention (OSAP), and the Office for Treatment Intervention (OTI). NIMH, NIAAA, and NIDA are now part of the National Institutes of Health (NIH).

    Approved with Limited Modifications (ALM)
    Refers to status of reviewed protocols. See the IRB Guidebook Section 6 for more.

    Assent
    Agreement by an individual not competent to give legally valid informed consent (e.g., a child or cognitively impaired person) to participate in research.

    Assurance
    A formal written, binding commitment that is submitted to a federal agency in which an institution promises to comply with applicable regulations governing research with human subjects and stipulates the procedures through which compliance will be achieved [Federal Policy §___.103].

    Authorized Institutional Official
    An officer of an institution with the authority to speak for and legally commit the institution to adherence to the requirements of the federal regulations regarding the involvement of human participants in biomedical and behavioral research.

    Autonomy
    Personal capacity to consider alternatives, make choices, and act without undue influence or interference of others.

    Autopsy
    Examination by dissection of the body of an individual to determine cause of death and other medically relevant facts.
  • Belmont Report
    A statement of basic ethical principles governing research involving human subjects issued by the National Commission for the Protection of Human Subjects in 1978. (http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html)

    Beneficence
    An ethical principle discussed in the Belmont Report that entails an obligation to protect persons from harm. The principle of beneficence can be expressed in two general rules: (1) do not harm; and (2) protect from harm by maximizing possible benefits and minimizing possible risks of harm.

    Benefit
    A valued or desired outcome; an advantage.

    Biologic
    Any therapeutic serum, toxin, anti-toxin, or analogous microbial product applicable to the prevention, treatment, or cure of diseases or injuries.

    Blind Study Designs
    See: Masked Study Designs; Double-Masked Design; and Single-Masked Design.
  • Cadaver
    The body of a deceased person.

    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. (See also: Retrospective Studies.)

    Centers for Disease Control and Prevention (CDC)
    An agency within the Public Health Service, Department of Health and Human Services.(www.cdc.gov)

    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 [45 CFR 46.401(a)].

    Children's Risk Level (CRL)
    CRL 1 (45 CFR 46.404)-Research not involving greater than minimal risk.

    CRL 2 (45 CFR 46.405)-Research involving greater than minimal risk but of possible direct benefit to the child, in which the risk is at least as favorable to the subject as that presented by available alternative approaches.

    CRL 3 (45 CFR 46.406)-Research involving greater than minimal risk and no prospect of direct benefit to the individual child, but likely to yield generalizable knowledge about the disorder or condition, in which the risk is minor relative to the potential improvement in knowledge to be applied to general understanding.

    CRL 4 (45 CFR 46.407)-Research not meeting the specifications above, but which presents an opportunity to understand, prevent or alleviate a serious problem affecting the health and welfare of children.

    For further information, see the form for Special Population Review - Children/Minors in Section 10, "Forms," of the UAB IRB Guidebook.

    Class I, II, III Devices
    Classification by the Food and Drug Administration of medical devices according to potential risks or hazards.

    Clinical Trial
    A controlled study involving human participants, designed to evaluate prospectively the safety and effectiveness of new drugs or devices or of behavioral interventions.

    Code of Federal Regulations (CFR)
    "The codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government. It is divided into 50 titles that represent broad areas subject to Federal regulation" (https://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR).

    Regulations related to human research are 45 CFR 46 (Tiitle 45 , Part 46) and for the FDA only 21 CFR 50 and 56 (Title 21, Parts 50 and 56).

    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 participants 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.

    Collaborative IRB Training Initiative (CITI)
    An online training program for researchers and staff, hosted at University of Miami. Register for initial or continuing IRB training.

    Common Rule
    Regulations that govern human subjects of research and have been adopted by seventeen federal agencies, as delineated in Title 45 of the Code of Federal Regulations Part 46 Subpart A

    Compensation
    Payment or medical care provided to participants injured in research; does not refer to payment (remuneration) for participation in research. (Compare: Remuneration.)

    Competence
    Technically, a legal term, used to denote capacity to act on one's own behalf; the ability to understand information presented, to appreciate the consequences of acting (or not acting) on that information, and to make a choice.

    Computerized Axial Tomography (CAT Scan)
    An X-ray technique for producing images of internal bodily structures through the assistance of a computer.

    Confidentiality
    Pertains to the treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others without permission in ways that are inconsistent with the understanding of the original disclosure.

    Consent
    See: Informed Consent.

    Contract
    An agreement; as used here, an agreement that a specific research activity will be performed at the request, and under the direction, of the agency providing the funds. Research performed under contract is more closely controlled by the agency than research performed under a grant. (Compare: 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 (Participants) or Controls
    Subject(s) used for comparison who are not given a treatment under study or who do not have a given condition, background, or risk factor that is the object of study. Control conditions may be concurrent (occurring more or less simultaneously with the condition under study) or historical (preceding the condition under study). When the present condition of participants is compared with their own condition on a prior regimen or treatment, the study is considered historically controlled.

    Correlation Coefficient
    A statistical index of the degree of relationship between two variables. Values of correlation coefficients range from -1.00 through zero to +1.00. A correlation coefficient of 0.00 indicates no relationship between the variables. Correlations approaching -1.00 or +1.00 indicate strong relationships between the variables. However, causal inferences about the relationship between two variables can never be made on the basis of correlation coefficients, no matter how strong a relationship is indicated.

    Crossover Design
    A type of clinical trial in which each participant experiences, at different times, both the experimental and control therapy. For example, half of the participants might be randomly assigned first to the control group and then to the experimental intervention, while the other half would have the sequence reversed.
  • Data and Safety Monitoring Board (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 participants about new information that might affect their willingness to continue in the trial.

    Data Use Agreements
    Data for a Limited Data Set must be collected according to the terms of "an agreement into which the covered entity enters with the intended recipient of a limited data set that establishes the ways in which the information in the limited data set may be used and how it will be protected." The data use agreement is the means by which a covered entity obtains satisfactory assurance that the recipient of the limited data set will use or disclose the PHI in the data set only for specific purposes. (See also: Limited Data Sets.)

    Dead Fetus
    An expelled or delivered fetus that exhibits no heartbeat, spontaneous respiratory activity, spontaneous movement of voluntary muscles, or pulsation of the umbilical cord (if still attached) [45 CFR 46.203(f)]. Generally, some organs, tissues, and cells (referred to collectively as fetal tissue) remain alive for varying periods of time after the total organism is dead.

    Debriefing
    Giving participants 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.)

    Declaration of Helsinki
    A code of ethics for clinical research approved by the World Medical Association in 1964 and widely adopted by medical associations in various countries. It was revised in 1975 and 1989. (http://www.who.int/bulletin/archives/79(4)373.pdf)

    Department of Health and Human Services (DHHS or USDHHS or HHS)
    A federal agency formerly known as the Department of Health, Education and Welfare (DHEW). (http://www.hhs.gov/)

    Department of Health, Education and Welfare (DHEW)
    A federal agency reorganized in 1980 as the Department of Health and Human Services (DHHS) and the Department of Education.

    Dependent Variables
    The outcomes that are measured in an experiment. Dependent variables are expected to change as a result of an experimental manipulation of the independent variable(s).

    Descriptive Study
    Any study that is not truly experimental (e.g., quasi-experimental studies, correlational studies, record reviews, case histories, and observational studies).

    Device (Medical)
    See: Medical Device.

    Diagnostic (Procedure)
    Tests used to identify a disorder or disease in a living person.

    Direct Identifiers Not Allowed in Limited Data Sets (HIPAA)
    A limited data set is described as health information that excludes certain, listed direct identifiers (see below) but that may include city; state; ZIP Code; elements of date; and other numbers, characteristics, or codes not listed as direct identifiers. The direct identifiers listed in the Privacy Rule's limited data set provisions apply both to information about the individual and to information about the individual's relatives, employers, or household members. The following identifiers must be removed from health information if the data are to qualify as a limited data set:

    • Names.
    • Postal address information, other than town or city, state, and ZIP Code.
    • Telephone numbers.
    • Fax numbers.
    • Electronic mail addresses.
    • Social security numbers.
    • Medical record numbers.
    • Health plan beneficiary numbers.
    • Account numbers.
    • Certificate/license numbers.
    • Vehicle identifiers and serial numbers, including license plate numbers.
    • Device identifiers and serial numbers.
    • Web universal resource locators (URLs).
    • Internet protocol (IP) address numbers.
    • Biometric identifiers, including fingerprints and voiceprints.
    • Full-face photographic images and any comparable images.
    (From http://privacyruleandresearch.nih.gov/pr_08.asp, "HIPAA Privacy Rule and Its Impacts on Research"

    Direct Identifiers That Must Be Removed for Data to be "De-Identified" (HIPAA)
    The following 18 identifiers must be removed for the information to be de-identified:

    • Names
    • Geographic subdivisions smaller than a State*
    • Elements of dates (except year) related to an individual*
    • Telephone numbers
    • Fax numbers
    • Email addresses
    • Social security numbers
    • Medical record numbers
    • Health plan beneficiary numbers
    • Account numbers
    • Certificate/license numbers
    • Vehicle identifiers and serial numbers
    • Device identifiers and serial numbers
    • Biometric identifiers
    • Web universal resource locators (URLs)
    • Internet protocol address numbers
    • Full-face photographic images
    • Any other unique identifying number (does not include codes as long as the research staff cannot link the data to an individual)*
    * See Limited Data Sets regarding these identifiers.

    Double-Masked Design
    A study design in which neither the investigators nor the participants know the treatment group assignments of individual participants. Sometimes referred to as "double-blind."

    Drug
    Any chemical compound that may be used on or administered to humans as an aid in the diagnosis, treatment, cure, mitigation, or prevention of disease or other abnormal conditions.
  • Emancipated Minor
    A legal status conferred upon persons who have not yet attained the age of legal competency as defined by state law (for such purposes as consenting to medical care), but who are entitled to treatment as if they had by virtue of assuming adult responsibilities such as being self-supporting and not living at home, marriage, or procreation. (See also: Mature Minor.)

    Embryo
    Early stages of a developing organism, broadly used to refer to stages immediately following fertilization of an egg through implantation and very early pregnancy (i.e., from conception to the eighth week of pregnancy). (See also: Fetus.)

    Epidemiology
    A scientific discipline that studies the factors determining the causes, frequency, and distribution of diseases in a community or given population.

    Equitable
    Fair or just; used in the context of selection of participants to indicate that the benefits and burdens of research are fairly distributed [Federal Policy §___.111(a)(3)].

    Ethics Advisory Board
    An interdisciplinary group that advises the Secretary, HHS, on general policy matters and on research proposals (or classes of proposals) that pose ethical problems.

    Ethnographic Research
    Ethnography is the study of people and their culture. Ethnographic research, also called fieldwork, involves observation of and interaction with the persons or group being studied in the group's own environment, often for long periods of time. (See also: Fieldwork.)

    Expanded Availability
    Policy and procedure that permits individuals who have serious or life-threatening diseases for which there are no alternative therapies to have access to investigational drugs and devices that may be beneficial to them. Examples of expanded availability mechanisms include Treatment INDs, Parallel Track, and open study protocols.

    Expedited Review
    Review of proposed research by the IRB chair or a designated voting member or group of voting members rather than by the entire IRB. Federal rules permit expedited review for certain kinds of research involving no more than minimal risk and for minor changes in approved research [Federal Policy §___.110].

    Experimental
    Term often used to denote a therapy (drug, device, procedure) that is unproven or not yet scientifically validated with respect to safety and efficacy. A procedure may be considered "experimental" without necessarily being part of a formal study (research) to evaluate its usefulness. (See also: Research.)

    Experimental Study
    A true experimental study is one in which participants are randomly assigned to groups that experience carefully controlled interventions manipulated by the experimenter according to a strict logic allowing causal inference about the effects of the interventions under investigation. (See also: Quasi-Experimental Study).
  • False Negative
    When a test wrongly shows an effect or condition to be absent (e.g., that a woman is not pregnant when, in fact, she is).

    False Positive
    When a test wrongly shows an effect or condition to be present (e.g. that is woman is pregnant when, in fact, she is not).

    Federal Policy (The)
    The federal policy that provides regulations for the involvement of human subjects in research. The Policy applies to all research involving human subjects conducted, supported, or otherwise subject to regulation by any federal department or agency that takes appropriate administrative action to make the Policy applicable to such research. Currently, sixteen federal agencies have adopted the Federal Policy. (Also known as the "Common Rule.")

    Fetal Material
    The placenta, amniotic fluid, fetal membranes, and umbilical cord.

    Fetus
    The product of conception from the time of implantation until delivery. If the delivered or expelled fetus is viable, it is designated an infant [45 CFR 46.203(c)]. The term "fetus" generally refers to later phases of development; the term "embryo" is usually used for earlier phases of development. (See also: Embryo.)

    Fieldwork
    Behavioral, social, or anthropological research involving the study of persons or groups in their own environment and without manipulation for research purposes (distinguished from laboratory or controlled settings). (See also: Ethnographic Research.)

    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."

    Food and Drug Adminstration (FDA)
    An agency of the federal government established by Congress in 1912 and presently part of the Department of Health and Human Services. (www.fda.gov)

    Full Board Review
    Review of proposed research at a convened meeting at which a majority of the membership of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. For the research to be approved, it must receive the approval of a majority of those members present at the meeting [Federal Policy §___.108].
  • Gene Therapy
    The treatment of genetic disease accomplished by altering the genetic structure of either somatic (nonreproductive) or germline (reproductive) cells.

    General Assurance
    Obsolete term, previously used to denote an institutional assurance covering multiple research projects. (See also: Assurance.)

    General Controls
    Certain FDA statutory provisions designed to control the safety of marketed drugs and devices. The general controls include provisions on adulteration, misbranding, banned devices, good manufacturing practices, notification and record keeping, and other sections of the Medical Device Amendments to the Food, Drug and Cosmetic Act [21 U.S. Code §360(c) (Food, Drug and Cosmetic Act §513)].

    Genetic Screening
    Tests to identify persons who have an inherited predisposition to a certain phenotype or who are at risk of producing offspring with inherited diseases or disorders.

    Genotype
    The genetic constitution of an individual.

    Grant
    Financial support provided for research study designed and proposed by the principal investigator(s). The granting agency exercises no direct control over the conduct of approved research supported by a grant. (Compare: Contract.)

    Guardian
    An individual who is authorized under applicable state or local law to give permission on behalf of a child to general medical care [45 CFR
  • Helsinki Declaration
    See: Declaration of Helsinki.

    Historical Controls
    Control participants (followed at some time in the past or for whom data are available through records) who are used for comparison with participants being treated concurrently. The study is considered historically controlled when the present condition of participants is compared with their own condition on a prior regimen or treatment.

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

    Human Subjects
    Participants whose physiologic or behavioral characteristics and responses are the object of study in a research project. Under the federal regulations, human subjects 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 [Federal Policy §___.102(f)].

    The Institute of Medicine, the National Bioethics Advisory Committee, and many others prefer participants for a generic term. They suggest using subjects, volunteers, and other such terms if necessary to refer to specific subsets of participants in a study.
  • In Vitro
    Literally, "in glass"; 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).

    Independent Variables
    The conditions of an experiment that are systematically manipulated by the investigator.

    Informed Consent
    A person's voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research or to undergo a diagnostic, therapeutic, or preventive procedure. In giving informed consent, participants 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].

    Institution (1)
    Any public or private entity or agency (including federal, state, and local agencies) [Federal Policy §___.102(b)].

    Institution (2)
    A residential facility that provides food, shelter, and professional services (including treatment, skilled nursing, intermediate or long-term care, and custodial or residential care). Examples include general, mental, or chronic disease hospitals; inpatient community mental health centers; halfway houses and nursing homes; alcohol and drug addiction treatment centers; homes for the aged or dependent, residential schools for the mentally or physically handicapped; and homes for dependent and neglected children.

    Institutional Review Board for Human Use (IRB)
    A specially constituted review body established or designated by an entity to protect the welfare of human subjects recruited to participate in biomedical or behavioral research [Federal Policy §§___.102(g), ___.108, ___.109].

    Institutionalized
    Confined, either voluntarily or involuntarily (e.g., a hospital, prison, or nursing home).

    Institutionalized Cognitively Impaired
    Persons who are confined, either voluntarily or involuntarily, in a facility for the care of the mentally or otherwise disabled (e.g., a psychiatric hospital, home, or school for the retarded).

    Investigational Device Exemption (IDE)
    Exemption 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 (IND)
    A drug permitted by FDA to be tested in humans but not yet determined to be safe and effective for a particular use in the general population and not yet licensed for marketing.

    Investigator
    In clinical trials, an individual who actually conducts an investigation [21 CFR 312.3]. Any interventions (e.g., drugs) involved in the study are administered to participants under the immediate direction of the investigator. (See also: Principal Investigator.)
  • Justice
    An ethical principle discussed in the Belmont Report requiring fairness in distribution of burdens and benefits; often expressed in terms of treating persons of similar circumstances or characteristics similarly.
  • Lactation
    The period of time during which a woman is providing her breast milk to an infant or child.

    Legally Authorized Representative (LAR) A person authorized either by statute or by court appointment to make decisions on behalf of another person. In human subjects 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 [Federal Policy §___.102(c)].

    If a legally authorized representative provides consent for a decisionally impaired adult to participate in a protocol, the person obtaining consent must attempt to find the following individuals in this order: (1) a legally appointed guardian; (2) a health care proxy or an individual authorized to make medical decisions in conjunction with a durable power of attorney; (3) a spouse; (4) an adult child; (5) a parent; or (6) next of kin.

    Limited Data Sets (LDS)
    Concerning the type of data collected, Limited Data Sets contain "PHI that excludes 16 categories of direct identifiers and may be used or disclosed, for purposes of research, public health, or health care operations, without obtaining either an individual's Authorization or a waiver or an alteration of Authorization for its use and disclosure, with a data use agreement." A limited data set may include city; state; ZIP code; elements of date; and other numbers, characteristics, or codes not listed as direct identifiers. Direct identifiers listed in the Privacy Rule's limited data set provisions apply both to information about the individual and to information about the individual's relatives, employers, or household members. (See also: Direct Identifiers Not Allowed in Limited Data Sets and Data Use Agreement.)

    Lod Score
    An expression of the probability that a gene and a marker are linked.

    Longitudinal Study
    A study designed to follow participants forward through time.
  • Masked Study Designs
    Study designs comparing two or more interventions in which either the investigators, the participants, or some combination thereof do not know the treatment group assignments of individual participants. Sometimes called "blind" study designs. (See also: Double-Masked Design; Single-Masked Design.)

    Mature Minor
    Someone who has not reached adulthood (as defined by state law) but who may be treated as an adult for certain purposes (e.g., consenting to medical care). Note that a mature minor is not necessarily an emancipated minor. (See also: Emancipated Minor.)

    Medical Device
    A diagnostic or therapeutic article that does not achieve any of its principal intended purpose through chemical action within or on the body. Such devices include diagnostic test kits, crutches, electrodes, pacemakers, arterial grafts, intraocular lenses, and orthopedic pins or other orthopedic equipment.

    Medical Device Amendments (MDAs)
    Amendments to the Federal Food, Drug and Cosmetic Act passed in 1976 to regulate the distribution of medical devices and diagnostic products.

    Mentally Disabled
    See: Cognitively Impaired.

    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
    A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed 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 [Federal Policy §___.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.

    For research involving children, research that does not involve greater than minimal risk requires both assent of the child and permission of at least one parent or guardian.

    The definition of minimal risk for research involving prisoners differs somewhat from that given for noninstitutionalized adults. [See 45 CFR 46.303(d) and Guidebook Chapter 6, Section E, "Prisoners."]

    Minimal is an adjective, as in "minimal risk"; minimum is a noun, as in "the acceptable minimum."

    Monitoring
    The collection and analysis of data as the project progresses to assure the appropriateness of the research, its design and subject protections.
  • National Commission
    National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. An interdisciplinary advisory body, established by Congressional legislation in 1974, which was in existence until 1978, and which issued a series of reports and recommendations on ethical issues in research and medicine, many of which are now embodied in federal regulations.

    National Institutes of Health (NIH)
    National Institutes of Health: a federal agency within the Public Health Service, DHHS, comprising 27 institutes and centers. It is responsible for carrying out and supporting biomedical and behavioral research.(www.nih.gov)
    • Office of the Director (OD)
    • National Cancer Institute (NCI)
    • National Eye Institute (NEI)
    • National Heart, Lung, and Blood Institute (NHLBI)
    • National Human Genome Research Institute (NHGRI)
    • National Institute on Aging (NIA)
    • National Institure on Alcohol Abuse and Alcoholism (NIAAA)
    • National Institute of Allergies and Infectious Diseases (NIAID)
    • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
    • National Institute of Biomedical Imaging and Bioengineering (NIBIB)
    • National Institute of Child Health and Human Development (NICHD)
    • National Institute on Deafness and Other Communication Disorders (NIDCD)
    • National Institute of Dental and Craniofacial Research (NIDCR)
    • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
    • National Institute on Drug Abuse (NIDA)
    • National Institute of Environmental Health Sciences (NIEHS)
    • National Institute of General Medical Sciences (NIGMS)
    • National Institute of Mental Health (NIMH)
    • National Institute of Neurological Disorders and Stroke (NINDS)
    • National Institute of Nursing Research (NINR)
    • National Library of Medicine (NLM)
    • Center for Information Technology (CIT formerly DCRT, OIRM, TCB)
    • Center for Scientific Review (CSR)
    • John E. Fogarty International Center (FIC)
    • National Center for Complementary and Alternative Medicine (NCCAM)
    • National Center on Minority Health and Health Disparities (NCMHD)
    • Warren Grant Magnuson Clinical Center (CC)
    New Drug Application (NDA)
    Request for FDA approval to market a new drug.

    "No Humans" Designation
    Review for "No Humans" is applicable for research activities that involve cadaveric materials, use of outdated blood products (from the Red Cross or other blood banks) or commercially available cell lines. See the IRB Guidebook Section 8 for more.

    Nonaffiliated 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).

    Nonsignificant Risk Device
    An investigational medical device that does not present significant risk to the patient. (See also: Significant Risk Device.)

    Nontherapeutic Research
    Research that has no likelihood or intent of producing a diagnostic, preventive, or therapeutic benefit to the current participants, although it may benefit subjects with a similar condition in the future.

    Nonviable 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.)

    Normal Volunteers
    Volunteer participants used to study normal physiology and behavior or who do not have the condition under study in a particular protocol, used as comparisons with participants who do have the condition. "Normal" may not mean normal in all respects. For example, patients with broken legs (if not on medication that will affect the results) may serve as normal volunteers in studies of metabolism, cognitive development, and the like. Similarly, patients with heart disease but without diabetes may be the "normals" in a study of diabetes complicated by heart disease.

    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. (https://history.nih.gov/research/downloads/nuremberg.pdf)
  • Office for Human Research Protections (OHRP)
    The office within the National Institutes of Health, an agency of the Public Health Service, Department of Health and Human Services, responsible for implementing DHHS regulations (45 CFR Part 46) governing research involving human subjects. Formerly known as the Office for Protection from Research Risks (OPRR). (http://www.hhs.gov/ohrp/)

    Office for Protection from Research Risks (OPRR)
    Former name of the Office for Human Research Protections (OHRP) (See also: Office for Human Research Protections)

    Office of the Institutional Review Board (OIRB)
    Refers to members of administration and staff who are not members of the Board; the OIRB carries out the recommendations of the IRB.

    Open Design
    An experimental design in which both the investigator(s) and the participants know the treatment group(s) to which participants are assigned.
  • Paternalism
    Making decisions for others against or apart from their wishes with the intent of doing them good.

    Permission
    The agreement of parent(s) or guardian to the participation of their child or ward in research [45 CFR 46.402(c)].

    Pharmacology
    The scientific discipline that studies the action of drugs on living systems (animals or human beings).

    Phase 1, 2, 3, 4 Drug Trials
    Different stages of testing drugs in humans, from first application in humans (Phase 1) through limited and broad clinical tests (Phase 3), to postmarketing studies (Phase 4).

    Phenotype
    The physical manifestation of a gene function.

    Placebo
    Some clinical studies compare an experimental treatment to another treatment. The non-experimental treatment is sometimes referred to as a "placebo," a word that comes from the Latin for "I shall please."

    Originally, placebos were drugs that were thought to have no medicinal effect (positive or negative). Such "drugs" were given to appease people who had physical or mental complaints of no known cause. In this context, placebos came to be known as "sugar pills."

    More recently, the word placebo has come to mean different things to different people. In the context of clinical trials, a "placebo treatment" often refers to treatment that is indistinguishable from the treatment that is under investigation. Most commonly, this would be a pill of capsule of the same size and color but containing a harmless, inactive substance.

    Participants have the right to know (a) whether they may be assigned to a placebo group and the probability of that assignment and (b) the nature of the placebo treatment.

    Portable Document Format (PDF)
    Computer file format used with programs like Adobe Acrobat and Adobe Acrobat Reader

    Possibly Related (used with Adverse Event Report)
    There is a reasonable possibility the adverse event may have been caused by the drug, device, or intervention; or it is possible that the adverse event may have been caused by the drug, device, or intervention, but there is insufficient information to determine the likelihood of this possibility.

    Postamendments Devices
    Medical devices marketed after enactment of the 1976 Medical Device Amendments.

    Preamendments Devices
    Medical devices marketed before enactment of the 1976 Medical Device Amendments.

    Preclinical Investigations
    Laboratory and animal studies designed to test the mechanisms, safety, and efficacy of an intervention prior to its applications to humans.

    Predicate Devices
    Currently legally marketed devices to which new devices may be found substantially equivalent under the 510(k) process.

    Pregnancy
    The period of time from confirmation of implantation of a fertilized egg within the uterus until the fetus has entirely left the uterus (i.e., has been delivered). Implantation is confirmed through a presumptive sign of pregnancy such as missed menses or a positive pregnancy test [45 CFR 46.203(b)]. This "confirmation" may be in error, but, for research purposes, investigators would presume that a living fetus was present until evidence to the contrary was clear. Although fertilization occurs a week or more before implantation, the current inability to detect the fertilization event or the presence of a newly fertilized egg makes a definition of pregnancy based on implantation necessary.

    Premarket Approval
    Process of scientific and regulatory review by the FDA to ensure the safety and effectiveness of Class III devices.

    President's Commission
    President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. An interdisciplinary advisory group, established by congressional legislation in 1978, which was in existence until 1983, and which issued reports on ethical problems in health care and in research involving human subjects.

    Principal Investigator
    The scientist or scholar with primary responsibility for the design and conduct of a research project. (See also: Investigator.)

    Prisoner
    An individual involuntarily confined in a penal institution, including persons: (1) sentenced under a criminal or civil statue; (2) detained pending arraignment, trial, or sentencing; and (3) detained in other facilities (e.g., for drug detoxification or treatment of alcoholism) under statutes or commitment procedures providing such alternatives to criminal prosecution or incarceration in a penal institution [45 CFR 46.303(c)].

    Privacy
    Control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others.

    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 participants to be studied. Prospective studies need not involve manipulation or intervention but may be purely observational or involve only the collection of data.

    Protocol
    The formal design or plan of an experiment or research activity; specifically, the plan submitted to an IRB for review and to an agency for research support. The protocol includes a description of the research design or methodology to be employed, the eligibility requirements for prospective participants and controls, the treatment regimen(s), and the proposed methods of analysis that will be performed on the collected data.

    Public Health Service (PHS)
    Part of the U.S. Department of Health and Human Services, it includes FDA, NIH, CDC, SAMHSA, and HRSA.

    Purity
    The relative absence of extraneous matter in a drug or vaccine that may or may not be harmful to the recipient or deleterious to the product.
  • Quasi-Experimental Study
    A study that is similar to a true experimental study except that it lacks random assignments of participants to treatment groups. (See also: Experimental Study.)
  • Radioactive Drug
    Any substance defined as a drug in §201(b)(1) of the Federal Food, Drug and Cosmetic Act that exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons [21 CFR 310.3(n)]. Included are any nonradioactive reagent kit or nuclide generator that is intended to be used in the preparation of a radioactive drug and "radioactive biological products," as defined in 21 CFR 600.3(ee). Drugs such as carbon-containing compounds or potassium-containing salts containing trace quantities of naturally occurring radionuclides are not considered radioactive drugs.

    Radioactive Drug Research Committee (RDRC)
    An institutional committee responsible for the use of radioactive drugs in human participants for research purposes. Research involving human participants that proposes to use radioactive drugs must meet various FDA requirements, including limitations on the pharmacological dose and the radiation dose. Furthermore, the exposure to radiation must be justified by the quality of the study and the importance of the information it seeks to obtain. The committee is also responsible for continuing review of the drug use to ensure that the research continues to comply with FDA requirements, including reporting obligations. The committee must include experts in nuclear medicine and the use of radioactive drugs, as well as other medical and scientific members [21 CFR 36.1].

    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.

    Radiopharmaceuticals
    Drugs (compounds or materials) that may be labeled or tagged with a radioisotope. These materials are largely physiological or subpharmacological in action, and, in many cases, function much like materials found in the body. The principal risk associated with these materials is the consequent radiation exposure to the body or to specific organ systems when they are injected into the body.

    Random (also Random Assignment, Randomization, Randomized)
    Assignment of participants to different treatments, interventions, or conditions according to chance rather than systematically (e.g., as dictated by the standard or usual response to their condition, history, or prognosis, or according to demographic characteristics). Random assignment of participants to conditions is an essential element of experimental research because it makes more likely the probability that differences observed between subject groups are the result of the experimental intervention.

    Recombinant DNA Technology
    "The ability to chop up DNA, the stuff of which genes are made, and move the pieces, [which] permits the direct examination of the human genome," and the identification of the genetic components of a wide variety of disorders [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.

    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.) (Compare: Compensation.)

    Research
    A systematic investigation (i.e., the gathering and analysis of information) designed to develop or contribute to generalizable knowledge [Federal Policy §___.102(d)].

    Respect for Persons
    An ethical principle discussed in the Belmont Report requiring that individual autonomy be respected and that persons with diminished autonomy be protected.

    Retrospective Studies
    Research conducted by reviewing records from the past (e.g., birth and death certificates, medical records, school records, or employment records) or by obtaining information about past events elicited through interviews or surveys. Case control studies are an example of this type of research.

    Review (of Research)
    The concurrent oversight of research on a periodic basis by an IRB. In addition to the at least annual reviews mandated by the federal regulations, reviews may, if deemed appropriate, also be conducted on a continuous or periodic basis [Federal Policy §___.108(e)].

    Review, Exemption from
    There are six approved categories for exemption, listed on the online Exemption Review Application. Only the IRB can grant exemption status. See the UAB IRB Guidebook Section 9, "IRB Exemption Review."

    Review, Expedited
    Expedited refers to 9 categories of research that may be reviewed through an expedited procedure-not to the length of time required for the review process. See the UAB IRB Guidebook Section 10, "IRB Expedited Review."

    Review, Full
    Protocols that do not meet the specifications for exemption or expedited review must be reviewed by the convened IRB. This process is called full review. See the UAB IRB Guidebook Section 11, "IRB Full Review."

    Risk (Magnitude and Likelihood)
    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.)

    The magnitude is the severity of the risk, and the likelihood is the probability of the risk occurring.

    Roentgen Equivalent in Man (REM)
    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.
  • Scientific Review Group
    A group of highly regarded experts in a given field, convened by NIH to advise NIH on the scientific merit of applications for research grants and contracts. Scientific review groups are also required to review the ethical aspects of proposed involvement of human participants. Various kinds of scientific review groups exist, and are known by different names in different institutes of the NIH (e.g., Study Sections, Initial Review Groups, Contract Review Committees, or Technical Evaluation Committees).

    Secretary
    A U.S. Cabinet Officer. In the context of DHHS-conducted or -supported research, usually refers to the Secretary of Health and Human Services.

    Significant Risk Device
    An investigational medical device that presents a potential for serious risk to the health, safety, or welfare of the subject.

    Single-Masked Design
    Typically, a study design in which the investigator, but not the subject, knows the identity of the treatment assignment. Occasionally the subject, but not the investigator, knows the assignment. Sometimes called "single-blind design."

    Site Visit
    A visit by agency officials, representatives, or consultants to the location of a research activity to assess the adequacy of IRB protection of human subjects or the capability of personnel to conduct the research.

    Social Experimentation
    Systematic manipulation of, or experimentation in, social or economic systems; used in planning public policy.

    Sponsor (of a Drug Trial)
    A person or entity that initiates a clinical investigation of a drug-usually the drug manufacturer or research institution that developed the drug. The sponsor does not actually conduct the investigation, but rather distributes the new drug to investigators and physicians for clinical trials. The drug is administered to participants under the immediate direction of an investigator who is not also a sponsor. A clinical investigator may, however, serve as a sponsor-investigator. The sponsor assumes responsibility for investigating the new drug, including responsibility for compliance with applicable laws and regulations. The sponsor, for example, is responsible for obtaining FDA approval to conduct a trial and for reporting the results of the trial to the FDA.

    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.

    Statistical Significance
    A determination of the probability of obtaining the particular distribution of the data on the assumption that the null hypothesis is true. Or, more simply put, the probability of coming to a false positive conclusion [See pg. 2 of McLarty, J. W., "How Many Subjects are Required for a Study?" IRB 9 (No. 5, September/October 1987): 1-3.]. If the probability is less than or equal to a predetermined value (e.g., 0.05 or 0.01), then the null hypothesis is rejected at that significance level (0.05 or 0.01).

    Sterility (1)
    The absence of viable contaminating microorganisms; aseptic state.

    Sterility (2)
    The inability to procreate; the inability to conceive or induce conception.

    Study Section
    See: Scientific Review Group.

    Subjects (Human)
    See: Human Subjects.

    Substance Abuse and Mental Health Services Administration (SAMSHA)
    Includes the Center for Substance Abuse Prevention, the Center for Substance Abuse Treatment and the Center on Mental Health Services. Formerly the Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA). (See also: ADAMHA.) (www.samhsa.gov/)

    Surveys
    Studies designed to obtain information from a large number of respondents through written questionnaires, telephone interviews, door-to-door canvassing, or similar procedures.
  • Therapeutic Intent
    The research physician's intent to provide some benefit to improving a subject's condition (e.g., prolongation of life, shrinkage of tumor, or improved quality of life, even though cure or dramatic improvement cannot necessarily be effected.) This term is sometimes associated with Phase 1 drug studies in which potentially toxic drugs are given to an individual with the hope of inducing some improvement in the patient's condition as well as assessing the safety and pharmacology of a drug.

    Therapy
    Treatment intended and expected to alleviate a disease or disorder.
  • Uniform Anatomical Gift Act
    Legislation adopted by all 50 States and the District of Columbia that indicates procedures for donation of all or part of a decedent's body for such activities as medical education, scientific research, and organ transplantation.
  • Vaccine
    A biologic product generally made from an infectious agent or its components - a virus, bacterium, or other microorganism - that is killed (inactive) or live-attenuated (active, although weakened). Vaccines may also be biochemically synthesized or made through recombinant DNA techniques.

    Variable (used as a noun)
    An element or factor that the research is designed to study, either as an experimental intervention or a possible outcome (or factor affecting the outcome) of that intervention.

    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 decision to participate (or to continue to participate) in a research activity.