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  • 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.

    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.

    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.

    Payment for participation in research. (NOTE: It is wise to confine use of the term "compensation" to payment or provision of care for research-related injuries.) (Compare: Compensation.)

    A systematic investigation (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.