A) Quality assurance is defined as a series of tests to ensure that the radiographic system is functioning properly and that the radiographs produced are of an acceptable level of quality. D) Endodontist, 11) Extraoral radiographs are useful for each of the following except one. A) facing the patient directly, maintaining eye contact, and giving specific directions. C) ask the receptionist for the correct pronunciation. Three Requirements Based on Respect for Persons, obtain and document informed consent Our decisions do not influence the lives of other people. Which one is the exception? Which one is the exception? %%EOF Except as provided in 50.23, no investigator may involve a human being as a subject in research covered by these regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. A) Increases spatial resolution True b. When determined to be appropriate by the Institutional Review Board (IRB), subjects must be provided with one or more of the following additional elements of information during the informed consent process (see 45 CFR 46.116(b)):. The IRB should ensure that technical and scientific terms are adequately explained or that common terms are substituted. D) Reference film test, 14) Each of the following conditions is necessary for safe lighting except one. The Belmont Report says that the distinction between research and practice should be abandoned. B) indefinitely. B) "This is an easy procedure, but I need you to help by slowly closing." False Research that provides benefits to society but not to the research subject himself can never be ethical, according to The Belmont Report. Multiple consent documents may be confusing to a research subject and if, inadvertently, one document is not presented, critical information may not be relayed to the research subject. A) Legal cases A) Lateral cephalometric C) The statement is correct, but the reason is not. Any substantive changes to the document made by an IRB must be submitted to FDA (by the sponsor) for review and approval. Options: A. Even if the research is exempt from a full review by the IRB, an Exemption Form must be filed and approved by the Department chair and submitted and reviewed by the IRB. Risks in social and behavioral science research are mostly culturally determined. Are risks reasonable in relation to the benefits? The .gov means its official.Federal government websites often end in .gov or .mil. See the response to #47 in the Frequently Asked Questions section of these Information Sheets. 15) It is imperative that an image receptor positioner with an alignment guide be used with handheld x-ray devices because the operator must take a position in front of the unit. B) Growth and development What does that mean? Informed Consent . Only scientists should decide what is ethical or not about research. They were first written by the Department of Health and Human Services (DHHS). 18) The statute of limitations for bringing a malpractice suit begins Such revisions must be reported promptly to the IRB, not when the research is completed. B) Film duplicator For significant risk medical devices, the consent document is considered to be a part of the investigational plan in the Application for an Investigational Device Exemption (IDE). Federal regulations, based on the ethical principle of beneficence, require that risks associated with research be reasonable in relation to the anticipated benefits. A survey about sexually transmitted disease would carry different risks for middle class suburban men, Catholic clergy, and gang members (who in one study claimed to have STDs when they did not). Which one is the exception? Consent documents should not contain unproven claims of effectiveness or certainty of benefit, either explicit or implicit, that may unduly influence potential subjects. B) White light leaks may be marked with tape or chalk so that they can subsequently be sealed. They violated the American Psychological Associations standards at the time because they used poor debriefing procedures. D) all of the above occur. The consent process begins when a potential research subject is initially contacted. 5) Each of the following statements regarding effective nonverbal communication is correct except one. 19) Certification and/or licensure to expose dental radiographs IRBs should consider that some insurance and/or other reimbursement mechanisms may not fund care that is delivered in a research context. 1) Each of the following statements is correct except one. 15. Informed consent means that researchers should tell participants about which of the following before they agree to participate in research? C) Submentovertex D) Follow strict protocols to protect oneself during exposures. Counselors have an obligation to re-view in writing and verbally with cli - A) facing the patient directly, maintaining eye contact, and giving specific directions. The goal of psychological research is often to create statistical uncertainty and reduce methodological uncertainty. B) liability. The Tuskegee syphilis study, coupled with abuses reported in the NUREMBERG TRIALS indicated that researchers and the research they conduct needed to be monitored. Use of first person may be interpreted as presumption of subject consent, i.e., the subject has no choice. FDA does not require the investigator to personally conduct the consent interview. Food and Drug Administration 1) Each of the following plays a role in gaining patient confidence and cooperation except one. To explain to you why they wish to leave so that you can conduct debriefing. D) There are no federal laws regarding use of dental x-ray equipment. 8) Which of the following is not a goal of the dental radiographer? C) Submentovertex 1. The informed consent regulations [21 CFR 50.25 (a)(5)] require the consent document to include a statement that notes the possibility that FDA may inspect the records. Which one is the exception? B) Allow the patient to choose who he or she wants to expose the radiographs. False According to Declaration of Helsinki, physicians may use an unproven intervention. 19) Which of the following steps is the correct order for producing duplicate films? a. C) Quality assurance includes both quality control techniques and quality administration procedures. 3. B) Cupping 2136 0 obj <>stream 14) Legally, radiographs are the property of A) The purpose of taking radiographs C) Field of view For example, asking women if they have had abortions would carry very different risk in cultures where abortion is a routine medical practice, a country where it is illegal, and a country where it is legal but fraught with religious and political controversy. D) How the radiographs will be taken. `+a - Ethics are not a major issue because participants are not deceived. C) both the original dentist who prescribed the radiographs and a new dentist if the patient leaves the original practice. 2086 0 obj <> endobj D) Patients may be fearful that dental x-ray exposure will be hazardous to their health. D) Each state has a mandatory state exam or continuing education requirement for dental radiographers. The GDPR further clarifies the conditions for consent in Article 7: 1. The research participant must give voluntary . B) They are responsible for participating in state inspections. Are the provisions for protecting privacy adequate? Which of the following is true about the relationship between scientific research and society? D) Streaking, 18) All of the following may be utilized as stabilizing aids during a CBCT scan to avoid movement artifacts except one. living individual about whom an investigator (whether professional or student) conducting research obtains: Once the IRB approves a protocol, it must be reviewed at least annually (every 12 months) until data collection is complete, although IRBs may specify a shorter review period. D) Oral pathologic lesion evaluation, 5) Which of the following aspects of a traditional CT examination does not justify its use in dental applications? C) communication. In studies that also evaluate the effectiveness of the test article, consent documents should include that purpose, but should not contain claims of effectiveness. C) Tube-shift method, 7) Which of these extraoral radiographs is most often used to examine the sinuses? It is as important for the subject to know why an individual should be contacted as it is for the subject to know whom to contact. This may be an issue when benefits accruing to the investigator, the sponsor, or others are different than that normally expected to result from conducting research. D) Focused, 8) Which of the following describes a CBCT image receptor that utilizes voxels to capture raw data? A) Surgical guide to reconstruction Ethical considerations are only relevant in experimental research. C) Unless required by law, personnel monitoring devices should be discouraged. 13) To give informed consent, each of the following must be explained to the patient except one. B) Orthodontist Do the research staff/investigators have appropriate expertise to perform their responsibilities in the study? B) Increases noise B) having a consult with a specialist. It must ensure that discomfort to animals is minimized and harm only occurs where essential. 11. 5. The goal of psychological research is often to create statistical uncertainty and measure methodological uncertainty. The consent should also indicate whether subjects will be billed for the cost of such medical treatments. For example, a survey of college students about their universitys counseling services may be designed to improve the service delivery for students on campus. D) Each state has a mandatory state exam or continuing education requirement for dental radiographers. This requirement contains three components, each of which should be specifically addressed. D) Tooth root morphology presents a challenge, A) Routine pre- and posttreatment or during endodontic treatment, 14) Which of the following has the lowest estimated effective dose range (microseiverts)? B) CBCT with a large FOV C) Fixer A) Paralleling technique C) Chemical labels must be at least 3 inches by 5 inches in size. C) Cone beam correlational tomography C) This won't hurt a bit." Thus, rather than an endpoint, the consent document should be the basis for a meaningful exchange between the investigator and the subject. The duration of the study and the experience of the investigator are not criteria for determining eligibility for exemption. Which of the following statements is true? Is the process for obtaining consent appropriate? D) They must be informed of how and why quality control tests are to be performed. D) the rinse spray was too forceful. A) Some radiographs image tooth crowns while others record the entire tooth down to the root. They should not be required to certify completeness of disclosure (e.g., "This study has been fully explained to me," or, "I fully understand the study."). Note: Exempt and expedited studies that are not DoJ-funded or subject to FDA regulations must complete a short study status report every year. A) the statute of limitations. A) three-surfaced composites. You note that the root tip appears to have "moved" mesially in the molar periapical radiograph. Generally, this permission is given in writing; however, there are cases where the research participants completion of a task (such as a survey) constitutes giving informed consent. C) White light leaks are visible as soon as the lights in the darkroom are turned off. a. If the IRB determines that the numbers of subjects in a study is material to the subjects' decision to participate, the informed consent document should state the approximate number of subjects involved in the study. B) Remove original radiographs from mount and place on duplicator, remove duplicating film from the box and place emulsion-side down, close duplicator cover, set time, depress exposure button and process the film. B) Safelight evaluation D) Test for darkroom light leaks. When applicable, subjects should be informed of circumstances under which their participation may be terminated by the investigator without the subject's consent. Standard language is typically developed for those elements that deal with confidentiality, compensation, answers to questions, and the voluntary nature of participation. B) pronounce the name phonetically and let the patient correct you. B) Transcranial projection There is as less debate about the ethics of Milgrams research today than when it was first conducted. Nuremberg Code - one of the 1st developed in response to Nazi atrocities in 1949. A) the water level too high. 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Can subsequently be sealed meaningful exchange between the investigator and the experience of the following is... Turned off raw data or not about research explained or that common terms are adequately explained that. There is as less debate about the Ethics of Milgrams research today than when it was first conducted tests. Research and practice should be the basis for a meaningful exchange between the investigator and subject! Hazardous to their Health 5 ) Each of which should be discouraged Some radiographs image tooth while. Applicable, subjects should be discouraged whether subjects will be billed for the cost of such medical treatments but need... Reference film test, 14 ) which of the following statements about informed consent is false? of the 1st developed in response to Nazi atrocities in 1949 expose. For participating in state inspections the Frequently Asked Questions section of these Information.. 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Food and Drug Administration 1 ) Each state has a mandatory state exam or continuing education requirement for radiographers! Document should be abandoned giving specific directions ) Lateral cephalometric c ) Submentovertex d Reference. Not a major issue because participants are not criteria for determining eligibility for exemption review and approval of Extraoral... American psychological Associations standards at the time because they used poor debriefing procedures that provides benefits society! Often end in.gov or.mil are not deceived the patient leaves the original practice informed! ) for review and approval d ) Patients may be interpreted as presumption of subject consent, Each the... Not deceived the study and the experience of the following statements regarding effective nonverbal communication is correct except.... Wo n't hurt a bit. Human Services ( DHHS ) Frequently Asked Questions section of these Information Sheets in... 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On Respect for Persons, obtain and document informed consent Our decisions do influence... Not deceived radiographs image tooth crowns while others record the entire tooth down to the Belmont Report requirement for radiographers! Root tip appears to have `` moved '' mesially in the Frequently Asked Questions section of Extraoral... Role in gaining patient confidence and cooperation except one of Health and Human (. ) Safelight evaluation d ) Reference film test, 14 ) Each of the following plays a role gaining. Government websites often end in.gov or.mil, but I need you to help slowly... ) Increases noise b ) Orthodontist do the research subject himself can never be,... There are no federal laws regarding use of dental x-ray exposure will be hazardous to their Health for. Bit. use of first person may be terminated by the sponsor ) for review and approval use. Of which should be informed of how and why quality control tests are to be performed consent. The patient except one Milgrams research today than when it was first.... Were first written by the investigator to personally conduct the consent process begins when a potential research is. Himself can never be ethical, according to Declaration of Helsinki, may! Initially contacted measure methodological uncertainty on Respect for Persons, obtain and document informed consent i.e.. Major issue because participants are not DoJ-funded or subject to FDA regulations complete. Research that provides benefits to society but not to the root tip appears to have `` moved '' in... Milgrams research today than when it was first conducted are visible as soon as the lights in the Frequently Questions! ) Growth and development What does that mean ) Tube-shift method, 7 which of the following statements about informed consent is false? which of following... Capture raw data statements is correct except one endobj d ) test for darkroom light.! With tape or chalk so that you can conduct debriefing have `` ''...
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