C) Cloud file sharing systems Our decisions do not influence the lives of other people. D) All of the above, 18) Which of the following best responds to this patient question: "How often should children have dental x-rays?" Informed Consent . A) "I know this is an uncomfortable procedure, so I'll be as quick as possible." Standard language is typically developed for those elements that deal with confidentiality, compensation, answers to questions, and the voluntary nature of participation. 2) Each of the following is an objective of quality control except one. The statement that the study involves research is important because the relationship between patient-physician is different than that between subject-investigator. D) Reference film test, 14) Each of the following conditions is necessary for safe lighting except one. Publication of the results is sometimes used as a measure of whether research is generalizable, but this is too narrow a measure for two reasons. Which of the following statements about informed consent is FALSE? 8@^"' Tt D) Lateral cephalometric, Instrument Identification 1: Basic Instruments, Chapter 29: Radiographic Techniques for Speci, Julie S Snyder, Linda Lilley, Shelly Collins, Barbara T Nagle, Hannah Ariel, Henry Hitner, Michele B. Kaufman, Yael Peimani-Lalehzarzadeh. They may be shared with colleagues through the Internet, appear in a dissertation, provided to Board members in a project report, or archived for future research). D) Use of the step-wedge to monitor the developer should occur at the end of each day. B) Safelight evaluation respect the privacy interests of research participants A) is regulated by individual state laws, which may vary. A) Speak to the patient in lay terms about the risks and benefits of exposing radiographs. If this technique is used, the initial document should explain that subjects will be asked to participate in the additional phases. Researchers are bound by a code of ethics that includes the following protections for subjects. B) "To protect you from possible scatter radiation." Informed consent can be given verbally, provided there is a witness. If no direct benefit is anticipated, that should be stated. When a short form consent document is to be used [21 CFR 50.27(b)(2)], the IRB should review and approve the written summary of the full information to be presented orally to the subjects. Subjects do not have the option to keep their records from being audited/reviewed by FDA. A) attitude. C) Tube-shift method, 7) Which of these extraoral radiographs is most often used to examine the sinuses? A) the water level too high. B) The Federal Performance Act of 1974 was designed to protect patients from unnecessary radiation. C) Chemical labels must be at least 3 inches by 5 inches in size. a. B) To apply the tube-shift method, two radiographs are needed. 11) When all three anatomical planes are viewed together, this is known as image A) A true test of the safelight uses a film preexposed to a small amount of radiation. C) when the patient ceases to be a patient. A) In the definitive evaluation method, objects on the buccal surface of the tooth will appear more clear and distinct on the image than objects on the lingual. Which one is the exception? B) liability. B) Medium 5) Each of the following statements regarding informed consent is correct except one. As researchers, we are bound by rules of ethics. A great deal of research in the social and behavioral sciences offers little potential for direct benefits to the subjects themselves. B) the dryer was not operating correctly. Investigational drug and biologic studies are not officially approved by FDA. D) Surgical tooth extraction, 3) Which of the following is a condition classified under the Not Necessary category regarding CBCT examinations? Imagine that you are conducting a psychological experiment that has been approved by your institutional ethics committee and two participants object to answering some questions which they consider to be too personal. A) A dental radiographic normalizing and monitoring device can be used to monitor the developer. The required signatures on a short form are stated in 21 CFR 50.27(b)(2). If FDA does not place the study on hold within the thirty day period, the study may begin (with IRB approval). C) Fixer A) from the date that treatment was started. Research involving survey procedures, interview procedures, or observations of public behavior providing that any disclosure of identifiable information outside the research setting would not place the subjects at risk of criminal or civil liability or be damaging to the subjects financial standing, employability, or reputation (Note: By institution choice, interviews with children and participant observation with children may not be exempt). A copy of the consent document must be provided to the subject and the original signed consent document should be retained in the study records. The goal of psychological research is often to create statistical uncertainty and measure methodological uncertainty. The explanation of risks of the test article should be based upon information presented in documents such as the protocol and/or investigator's brochure, package labeling, and previous research study reports. D) establishes standards for state certification/licensure of radiographic personnel. B) They must be competent in exposing, processing, and mounting dental radiographs. You note that the root tip appears to have "moved" mesially in the molar periapical radiograph. C) Data receptors -patient must be competent to make an informed decision. The informed consent documentation requirements [21 CFR 50.27] permit the use of either a written consent document that embodies the elements of informed consent or a "short form" stating that the elements of informed consent have been presented orally to the subject. Three Basic Ethical Principles Outlined in the Belmont Report, Respect for Persons (Treat individuals as autonomous human beings, capable of making their own decisions and choices, and do not use people as a means to an end) Informed consent documents should describe any compensation or medical treatments that will be provided if injury occurs. 16) Which technique is recommended when exposing intraoral postmortem radiographs for forensic identification? assessing the patient's ability to understand the nature of the condition and various treatment options/outcomes . Risks in social and behavioral science research are mostly culturally determined. A) Keep retake radiographs under three per patient. D) All of the above, 18) Duplicate radiographs are needed for all of the following except for one. B) X-ray film A) Routine pre- and posttreatment or during endodontic treatment To complete the experimental session because you would not ask personal questions unless they were really important for science. Whichever document is used, a copy must be given to the person signing the document. 2020SAGE Publications SAGE Publications India Pvt. 2136 0 obj <>stream When withdrawal from a research study may have deleterious effects on the subject's health or welfare, the informed consent should explain any withdrawal procedures that are necessary for the subject's safety and specifically state why they are important to the subject's welfare. in the Counseling Relationship . A) Some radiographs image tooth crowns while others record the entire tooth down to the root. False Research that provides benefits to society but not to the research subject himself can never be ethical, according to The Belmont Report. B) from the date that treatment was completed. C) An additional radiograph would be required to determine the buccal or lingual location of the impacted retained primary root tip. B) The patient C) The statement is correct, but the reason is not. Use of first person may be interpreted as presumption of subject consent, i.e., the subject has no choice. Establishment of the National Research Act B) risk management. Any substantive changes to the document made by an IRB must be submitted to FDA (by the sponsor) for review and approval. B) Developer D) Black darkroom walls, 15) Which of the following indicates a passed coin test? The DHHS regulations are often referred to as 45 CFR 46. Therefore, absolute protection of confidentiality by FDA should not be promised or implied. A) Solution levels must be replenished and changed on a regular basis. Consent documents for studies of investigational articles should include a statement that a purpose of the study includes an evaluation of the safety of the test article. Any procedures relating solely to research (e.g., randomization, placebo control, additional tests ) should be explained to the subjects. An unexplained statement that the subject will be asked to submit to tests prior to withdrawal, does not adequately inform the subjects why the tests are necessary for the subject's welfare. The research participant must give voluntary . Consent documents are more understandable if they are written just as the clinical investigator would give an oral explanation to the subject, that is, the subject is addressed as "you" and the clinical investigator as "I/we." Also see these FDA guidance documents about acceptance of clinical data: Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions). They led to important developments in ethical principles in psychological research. C) self-determination. C) Inform the patient about the risks of radiation exposure. In some cultures, it is "normal" for a husband to make decisions on behalf of his wife, and the wife can be enrolled in the study as long as it is not against her will B. Minors can provide consent as long as they completely understand the risks and benefits of a study The investigator then photocopies the consent document for use. A nurse is caring for a client who has given informed consent for ECT. A) Lateral skull projection If a researcher has completed data collection and is only analyzing data and writing the research results, then IRB renewals are no longer required. and then select . This often means making sure that responses are anonymous. What research principle is this a glossary definition of? D) Intensifying screens should be cleaned daily with solutions recommended by the manufacturer. 1. 5630 Fishers Lane, Rm 1061 11) Which of the following statements would be acceptable communication with a patient? Risks in social and behavioral sciences generally fall into three categories (in rare circumstances the risk may be physical such as a study of victims of domestic violence who may become the victims of retaliatory violence): When assessing risk associated with participation in a research study, there are two distinct elements of risk that need to be considered. A) Caries detection A) Cone beam computed time The explanation of risks should be reasonable and should not minimize reported adverse effects. $`2h z2H1D@p$$X@".b0 LAu@Ul:D E!4:;=^/@ZU LW=3HlRR,S?d2k8Gw cR: Identifiable private information (a) information about behaviors that occur in a context where the individual can reasonably expect that no observations or recording is taking place or b) information that is provided for a specific purpose and for which the individual can reasonably expect will not be made public). Ethical uncertainty has no place in good psychological research. B) Multiple images that are identical in density and contrast indicate a failed test. A) the statute of limitations. A) Environmental Protection Agency (EPA) Is this statement a waiver . A patient must never be forced to sign a consent form To ensure that all patients properly understand the consent form, always use the same language to explain it. B) Identify problems as soon as image quality is compromised. C) A coin is placed on top of the unwrapped film for 10 minutes. C) may or may not be regulated by the dentist/employer. Before sharing sensitive information, make sure you're on a federal government site. B) A faint image of the coin D) A coin test uses a coin and a lightly exposed film to determine safelight adequacy. C) evaluate tube head stability. 1) What does CBCT stand for? D) is required by law in all 50 states and the District of Columbia. 11) Which of the following allow storage of documents and data as well as electronic access to image viewing software and provide an option for sharing large files? A) Scatter Prior to participating in any activity, I will ensure that all jewellery, mobile phones, keys, sharp objects, glasses, false nails, and any other valuables are removed by all Participants. A) Every 6 months C) ask the receptionist for the correct pronunciation. A) Direct supervision means the dentist is in the office when radiographs are being exposed. D) Increases movement artifacts, 20) A CBCT examination produces as many as ________ image slices available for interpretation (including all three anatomical planes). The witness must sign both the short form and a copy of the summary, and the person actually obtaining the consent must sign a copy of the summary. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: To obtain fibroblasts, skin punches were performed following written informed consent from the donor. Consent of the data subject means any freely given, specific, informed and unambiguous indication of the data subject's wishes by which he or she, by a statement or by a clear affirmative action, signifies agreement to the processing of personal data relating to him or her. This protects identifiable research information from forced disclosure. A) Nonverbal communication is not very believable. The benefits of the research often lie in the importance of the knowledge to be gained. 4) The federal Consumer-Patient Radiation Health and Safety Act The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. The principle of respect recognizes the capacity and rights of all individuals to . A) Disinfectant The goal of psychological research is often to create statistical uncertainty and reduce methodological uncertainty. This latter element requires that before the acceptance of an affirmation decision by the participant there should be made known to them the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon their health or person which may possibly come from their participation in the study. A) Temperature (C) The Formplus medical authorization form allows schools to collect formal consent from parents and guardians, in the case of a medical emergency involving their wards. D) all of the above occur. One function of Institutional Review Boards is to provide this independent assessment. Each university that receives federal funds (and most do) must have an Institutional Review Board (IRB) that reviews all research conducted at the university. For IND studies, the IRB should assure that the clinical investigator submits the investigator's brochure (when one exists) with the other study materials for review. C) They must know when to prescribe dental radiographs. Do the research staff/investigators have appropriate expertise to perform their responsibilities in the study? 4) Which localization technique requires the exposure of only one radiograph? Certain types of studies qualify for exempt or expedited review. 7. 3) Which of the following statements regarding localization methods is false? B) Image quality D) test the strength of processing chemicals. D) The definitive method of localization is the least reliable. C) Periodontal evaluation Risks and Benefits Researchers tend to underestimate risks involved in activities with which they are familiar and to overestimate the benefits of things that are important to them. ) Medium which of the following statements about informed consent is false? ) Each of the impacted retained primary root tip appears to have moved... For subjects, we are bound by rules of ethics patient & # x27 s... Was completed between subject-investigator additional phases to important developments in ethical principles in psychological research ) Each of knowledge. Ethical uncertainty has no place in good psychological research and changed on a Federal government site Which may.! 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