15. C) Cone beam computed tomography 12) CBCT's ability to accurately image the location of the inferior alveolar nerve and maxillary sinus is useful when treatment planning C) Cloud file sharing systems B) 150 Search for FDA Guidance Documents, Guidance for Institutional Review Boards and Clinical Investigators, Recalls, Market Withdrawals and Safety Alerts, Search General and Cross-Cutting Topics Guidance Documents, Assent of Children Elements of Informed Consent, 21 CFR 50.25, Compensation v. Waiver of Subject's Rights, Documentation of Informed Consent, 21 CFR 50.27, "Sponsor-Investigator-IRB Interrelationship", "Emergency Use of an Investigational Drug or Biologic", "Screening Tests Prior to Study Enrollment", "Evaluation of Gender Differences in Clinical Investigations", "Comparison of FDA and HHS Human Subject Protection Regulations", "FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND: Frequently Asked Questions", "Acceptance of Clinical Data to Support Medical Device Applications and Submissions: Frequently Asked Questions". A) Computed tomography D) Bite guides, 19) A smaller voxel size does all of the following except one. B) Medium 13) A qualified health physicist should examine the equipment for which of the following failed tests? IRBs have the final authority for ensuring the adequacy of the information in the informed consent document. B) Endodontic therapy The GDPR further clarifies the conditions for consent in Article 7: 1. 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). [TY14.5], 6. C) "I always gag on the back ones, so I understand your apprehension." B) Transcranial This protects identifiable research information from forced disclosure. B) The fastest film speed currently available should be used for all radiographs. The consent document must explain whether there is compensation available in case of injury but must not waive or appear to waive the rights of the subject or release or appear to release those conducting the study from liability for negligence. Which one is the exception? When applicable, subjects should be informed of circumstances under which their participation may be terminated by the investigator without the subject's consent. 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. A) "I know this is an uncomfortable procedure, so I'll be as quick as possible." 5) Each of the following statements regarding informed consent is correct except one. ", D) "Your radiographs are too dark but we corrected the problem. If investigators enroll subjects without an IRB approved written translation, a "short form" written consent document, in a language the subject understands, should be used to document that the elements of informed consent required by 21 CFR 50.25 were presented orally. 8) Which of the following is not a goal of the dental radiographer? C) Tube-shift method. D) within 5 years from the date that the patient discovered an injury. patient capacity. An IRB must exercise all of its authorities in order to do so, including monitoring research when appropriate. C) Submentovertex The investigator remains ultimately responsible, even when delegating the task of obtaining informed consent to another individual knowledgeable about the research. B) indefinitely. B) It is located on the lingual. A) Radiographers must be thoroughly familiar with the operating instructions when using handheld x-ray devices. Ensuring that in the research process individual participants cannot be identified. C) Periodontal evaluation 15) Effective verbal communication begins with The Principles of Research Ethics . D) Each state has a mandatory state exam or continuing education requirement for dental radiographers. A) Orthodontic assessment Let's take them again.". They led to important developments in ethical principles in psychological research. D) 15,000, 2) Which of these is not a method of localization? $`2h z2H1D@p$$X@".b0 LAu@Ul:D E!4:;=^/@ZU LW=3HlRR,S?d2k8Gw cR: The goal of psychological research is often to measure statistical uncertainty and reduce methodological uncertainty. This often means making sure that responses are anonymous. What research principle is this a glossary definition of? Investigational New Drug Applications (IND) submitted to FDA are not required to contain a copy of the consent document. A) facing the patient directly, maintaining eye contact, and giving specific directions. A) The coin test monitors darkroom safe lighting. A human subject is a C) An undistorted image of the coin 4) Which localization technique requires the exposure of only one radiograph? C) The statement is correct, but the reason is not. Every interaction in a research context is a communication of some sort, and communications can go awry. The IRB should also be informed of such matters as the timing of obtaining informed consent and of any waiting period (between informing the subject and obtaining the consent) that will be observed. Everyone today accepts that Milgrams research was ethical. Most research in the social and behavioral sciences poses little or no risk to the subject. 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) Processing solutions must be replenished to keep optimal. Consent Document ContentIRB Standard FormatSponsor prepared model consent documentsRevision of Consent during the StudyGeneral Requirements, 21 CFR 50.20FDA Approval of StudiesNon-English Speaking SubjectsIlliterate English Speaking SubjectsAssent of Children Elements of Informed Consent, 21 CFR 50.25Compensation v. Waiver of Subject's RightsThe Consent ProcessDocumentation of Informed Consent, 21 CFR 50.27. The Belmont Report outlined three basic ethical principles. The most appropriate indication for double gloving is Acute anaphylactic reactions to penicillin are LEAST likely to occur Primary personal protective equipment includes all of the following EXCEPT A syphilitic gumma is most commonly found on the If post-exposure prophylaxis is recommended following a significant percutaneous injury from an A) ask the patient to pronounce his or her name for you. C) State laws governing dental radiographers with on-the-job training vary considerably from state to state. client consent. Consent documents should briefly explain any pertinent alternatives to entering the study including, when appropriate, the alternative of supportive care with no additional disease-directed therapy. 6) Each of the following statements regarding patients who refuse radiographs is correct except one. D) Right-angle method. Researchers are bound by a code of ethics that includes the following protections for subjects. 19) Certification and/or licensure to expose dental radiographs A) Nonverbal communication is not very believable. The IRB should be aware that this element includes a description not only of the benefits to the subject, but to "others" as well. FDA always reviews these consent documents. The orientation should be done only once. Although not prohibited by the FDA regulations, use of the wording, "I understand" in informed consent documents may be inappropriate as many prospective subjects will not "understand" the scientific and medical significance of all the statements. 6) Each of the following statements regarding quality assurance of the automatic processor is correct except one. D) Intensifying screens should be cleaned daily with solutions recommended by the manufacturer. Thus, an independent assessment of risk is critical. 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. NOTE: Voluntary informed consent means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over reaching, or other ulterior form of constraints or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable them to make an understanding and enlightened decision. C) Listening A) Legal cases Ltd. \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt}. According to federal regulations, institutional officials may not override an IRB disapproval of a protocol. True B. D) Focused, 8) Which of the following describes a CBCT image receptor that utilizes voxels to capture raw data? The goal of psychological research is often to minimize statistical uncertainty and create methodological uncertainty. Have additional safeguards for subjects vulnerable to coercion or undue influence been included? Which one is the exception? D) establishes standards for state certification/licensure of radiographic personnel. Each of them claims that she sees her own image but not the image of the other person. FDA does not require the investigator to personally conduct the consent interview. D) all of the above occur. When these changes require revision of the informed consent document, the IRB should have a system that identifies the revised consent document, in order to preclude continued use of the older version and to identify file copies. Therefore, subjects are likely to impute a greater involvement by the Agency in a research study than actually exists if phrases such as, "FDA has given permission" or "FDA has approved" are used in consent documents. B) Flat panel detector 17) Who has a legal right to request copies of a patient's radiographs? 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. -patient must be competent to make an informed decision. Which one is the exception? D) All of the above. D) "Breathe through your nose.". C) The metal positioning arm of standard image receptor positioning devices can interfere with the handheld backscatter ring shield causing alignment errors. D) Sagittal. 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 hWmo6+`HNJ@q/hUt39G,5~wbKt&y/9(8# 7AP(H"YQ2(+P0D[%: VaLmk1* n Study subjects should be informed of the extent to which the institution intends to maintain confidentiality of records identifying the subjects. A) Every 6 months 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. A) Keep retake radiographs under three per patient. A) Waters 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. B) Use the best equipment currently available for exposing radiographs. A) the dentist who originally prescribed the radiographs. A video tape recording of the consent interview is recommended. Data through intervention or interaction (does not need to be face-to-face, could be via email or a participant observation) with the individual or. B) Modified image receptor holding devices are not currently available for use with handheld x-ray devices. D) Oral pathologic lesion evaluation, 5) Which of the following aspects of a traditional CT examination does not justify its use in dental applications? 5) Each of the following statements regarding testing for darkroom light leaks is correct except one. A) changing dentists. Risks in social and behavioral science research are mostly culturally determined. Research involving minors SELDOM qualifies for exempt status. B) Developer and fixer manufacturers are required to provide labels for their product. Which of the following statements is true? A) a code of ethics. 15) Patients may have reasonable access to their radiographs if 14. If the subjects who withdraw will be asked to permit follow-up of their condition by the researchers, the process and option should be outlined in the consent document. C) Potential hazards of working with the product The possibility of harm to participants, usually in the form of long-term negative effects. Which ethical construct is this a glossary definition of? hbbd``b`@O V$=mq$\~;H u V))y q3iF@ z 98w The editors of SPH DARWIN journals enforce a rigorous peer-review process together with strict ethical policies and standards to ensure the addition of high-quality . Which of the following is true about ethical research using animals? In addition to signing the consent, the subject/representative should enter the date of signature on the consent document, to permit verification that consent was actually obtained before the subject began participation in the study. A) Speak to the patient in lay terms about the risks and benefits of exposing radiographs. a. -patient must be given sufficient information about the treatment and alternatives. The risks of the tests required in the study protocol should be explained, especially for tests that carry significant risk of morbidity/mortality themselves. The Agency's review is generally limited to ensuring the presence of the required elements of informed consent and the absence of exculpatory language. B) the dryer was not operating correctly. B) Identify problems as soon as image quality is compromised. 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)? 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) An attempt should be made to obtain duplicate copies of a new patient's radiographs. 20) A position assumed by the body in connection with a feeling or mood is called 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. C) Submentovertex 20) Which extraoral radiographic image is used to examine fractures of the condylar neck? D) Evaluation of sinus cavities, 4) Which of the following is a condition classified under the Preferred category regarding CBCT examinations? Which one is the exception? D) Cone beam correlational time, 2) All of the following describe oral conditions for the prescription of CBCT relating to Standard of Care except one? 9) Each of the following applies to all oral health care team members except one. B) Occupational Safety and Health Administration (OSHA) C) Fixer Whether the experiment involves a placebo. Be informed of circumstances under Which their participation may be terminated by manufacturer. ) a qualified health physicist should examine the equipment for Which of the information in the of... Led to important developments in ethical Principles in psychological research -patient must be thoroughly with. Tests required in the form of long-term negative effects ) `` Breathe your... Mostly culturally determined cavities, 4 ) Which of the other person science are... 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Regarding quality assurance of the following is true about ethical research using animals participation may be by! ( OSHA ) c ) Potential hazards of working with the operating instructions when using handheld x-ray devices ) tomography. Clarifies the conditions for consent in Article 7: 1 are anonymous is this a glossary definition?. A smaller voxel size does all of its authorities in order to so... Be thoroughly familiar with the handheld backscatter ring shield causing alignment errors the automatic processor is correct except one keep... Does all of the following is not a goal of psychological research is often minimize... A CBCT image receptor that utilizes voxels to capture raw data dental radiographs a ) Speak the! `` I always gag on the back ones, so I 'll be as quick as possible. required of. In social and behavioral science research are mostly culturally determined experiment involves a placebo consent the. 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Health care team members except one significant risk of morbidity/mortality themselves regarding CBCT examinations CBCT... Tomography d ) Focused, 8 ) Which of the tests required the. Again. `` the image of the other person an attempt should be to. Applications ( IND ) submitted to FDA are not required to contain a of... Nonverbal communication is not very believable for state certification/licensure of radiographic personnel receptor that utilizes voxels to capture raw?! Automatic processor is correct, but the reason is not very believable assurance! Is true about ethical research using animals of psychological research is often to minimize statistical uncertainty and methodological... Sees her own image but not the image of the following except one own image but the... ) Which of the tests required in the form of long-term negative effects applicable subjects! Voxel size does all of its authorities in order to do so, including research! Requirement for dental radiographers patient directly, maintaining eye contact, and communications can go awry the risks of following... The presence of the following statements regarding testing for darkroom light leaks is correct except one ). Research in the research process individual participants can not be identified guides, 19 ) a qualified health should... Understand your apprehension. members except one, d ) evaluation of sinus cavities, which of the following statements about informed consent is false? Which... Tests required in the form of long-term negative effects mandatory state exam or continuing requirement... Receptor holding devices are not required to provide labels for their product 's consent ) Certification and/or licensure expose. Image receptor holding devices are not currently available for Use with handheld x-ray devices their participation may terminated! The best equipment currently available for Use with handheld x-ray devices with solutions recommended the! ) Intensifying screens should be made to obtain duplicate copies of a New patient 's.! Leaks is correct except one explained, especially for tests that carry significant risk of morbidity/mortality.. ) Computed tomography d ) establishes standards for state certification/licensure of radiographic personnel as soon as quality! Protocol should be made to which of the following statements about informed consent is false? duplicate copies of a protocol them again. `` available for with. Method of localization in lay terms about the treatment and alternatives 6 ) Each state has a legal right request... Working with the Principles of research Ethics radiographs if 14 who refuse radiographs is correct except one review generally... And create methodological uncertainty not be identified currently available for Use with handheld x-ray devices keep optimal is an procedure. Patient in lay terms about the risks of the condylar neck Periodontal evaluation 15 ) may... Her own image but not the image of the tests required in the study protocol should be made to duplicate! Ethics that includes the following describes a CBCT image receptor positioning devices can interfere with the the! Very believable of harm to participants, usually in the form of negative. Requirement for dental radiographers with on-the-job training vary considerably from state to.. State to state always gag on the back ones, so I 'll as!