Pregnant women, fetuses, neonates, children, and prisoners are considered vulnerable populations and are provided additional protection in the DHHS regulations. The orientation should be done only once. 5) Each of the following statements regarding effective nonverbal communication is correct except one. B) Cupping 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. [TY14.3], 4. 8) Which of the following is the ability to share in another's emotions or feelings? This process may be useful for studies with separate and distinct, but linked, phases through which the subject may proceed. A) The Consumer-Patient Radiation Health and Safety Act was designed to protect patients from unnecessary radiation. Is the process for obtaining consent appropriate? C) Lead apron The Common Rule does not include requirements for formatting protocols for IRB review. B) "This is an easy procedure, but I need you to help by slowly closing." When the study subject population includes non-English speaking people or the clinical investigator or the IRB anticipates that the consent interviews will be conducted in a language other than English, the IRB should require a translated consent document to be prepared and assure that the translation is accurate. -patient must voluntarily give consent. %%EOF C) Listening Subjects might think that, because the IRB had approved the research, there is no need to evaluate the study for themselves to determine whether or not they should participate. 5) Each of the following statements regarding testing for darkroom light leaks is correct except one. D) Black darkroom walls, 15) Which of the following indicates a passed coin test? For example, a survey of college students about their universitys counseling services may be designed to improve the service delivery for students on campus. Decisions about research ethics are always a matter of personal choice. The consent document should provide the name of a specific office or person and the telephone number to contact for answers to questions about: 1) the research subjects' rights; 2) a research-related injury; and 3) the research study itself. B) a new dentist if the patient leaves the original practice. As required by 21 CFR 50.27, a copy of the consent document must be given to each subject. B) empathy. A) No image of a coin Let's see if it will affect your radiographs." Why do batteries go dead, but fuel cells do not? B) Transcranial B) The Federal Performance Act of 1974 was designed to protect patients from unnecessary radiation. Which of the following statements about informed consent is false? C) Safe distance from working area This element requires that subjects be informed that they may decline to participate or to discontinue participation at any time without penalty or loss of benefits. B) Maintenance procedures and tests need to be performed annually under normal conditions. D) Requirements for safe handling and storage, A) The amount of product the practice can legally store. 9) Which of these statements is false? Research participants have the right to refuse to participate without penalty if they wish. Married minors may sign their own consent for treatment Any adult over 18 years of age may sign his or her own 13. Which one is the exception? D) Radiographer preference. D) Patients may be fearful that dental x-ray exposure will be hazardous to their health. Milgram had no regard for ethical issues. The explanation of risks should be reasonable and should not minimize reported adverse effects. B) They are responsible for participating in state inspections. A) Speak to the patient in lay terms about the risks and benefits of exposing radiographs. B) When the developer solution oxidizes and deteriorates, the radiographic images darken. C) "To assist with holding you still in the chair." D) Posteroanterior projection, 9) Which of these extraoral radiographs is most often used to show the base of the skull? The goal of psychological research is often to measure statistical uncertainty and reduce methodological uncertainty. 7) Which of the following is the best response to the patient inquiry, "Why do I need so many different types of radiographs?". 8@^"' Tt D) Sagittal plane, 7) What FOV classification for CBCT would be indicated for localizing the lower right arch? D) Multiplanar images, 6) Which of the following describes the area of interest that will be exposed during the scanning process? A) They should be provided with training opportunities to assure competency. An Authorization can be combined with an informed consent document or other permission to participate in research. C) Fanning 10) Each of the following is a safety protocol standard except one. B) Cone beam computed tomography 11) Which of the following statements would be acceptable communication with a patient? Which one is the exception? 13) All of the following are indications for using CBCT during endodontic treatment planning except one. B) Processing solutions must be replenished to keep optimal. `AC#d0f""Vb"#HR$Nd$b,H$Hx\$U^eS;spH].=M. Anything that is likely to affect the participants decision to participate in the research. B) "To protect you from possible scatter radiation." B) pronounce the name phonetically and let the patient correct you. Which one is the exception? A) "In case you are pregnant." 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 . A) Paralleling technique In the case of non-English speaking subjects, this would be the translated document. 9) What is the first step to open communication and meaningful patient education? Also, consent documents should not state or imply that FDA needs clearance or permission from the subject for access. C8X:ma9PBoGA 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. C) Aim for perfection with each radiograph. Which of the following is true regarding the impacted retained primary root tip? B) Growth and development A) facing the patient directly, maintaining eye contact, and giving specific directions. A. If no direct benefit is anticipated, that should be stated. The investigator then photocopies the consent document for use. Informed Consent . [TY14.4], 5. Research involving the collection or study of existing data (collected prior to the research for purposes other than the research) if the data is publicly available or recorded by the investigator in such a manner that the subjects cannot be identified. C) Use in mobile clinics C) A coin is placed on top of the unwrapped film for 10 minutes. A nurse is caring for a client who has given informed consent for ECT. 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? B) Increases noise The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. They used inadequate follow-up procedures. designed to develop or contribute to generalizable knowledge (An essential consideration is whether it is the intention of the investigator to contribute to generalizable knowledge). A) Unexplained gingival bleeding 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. 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. The consent form should document the method used for communication with the prospective subject and the specific means by which the prospective subject communicated agreement to participate in the study. A) Dental film Each of them claims that she sees her own image but not the image of the other person. D) How the radiographs will be taken. 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. A) Scatter Have additional safeguards for subjects vulnerable to coercion or undue influence been included? C) Periodontal evaluation The participants have no responsibilities, they can leave at any time. a. Investigational New Drug Applications (IND) submitted to FDA are not required to contain a copy of the consent document. D) Establish a written quality assurance system for radiographic equipment. FDA urges IRBs to question any study that appears to limit enrollment based on gender and/or minority status. C) Definitive evaluation method When a sponsor submits a study to FDA as part of the initial application for an investigational new drug (IND), FDA has thirty days to review the application and place the study on "hold" if there are any obvious reasons why the proposed study should not be conducted. Please indicate if the following statements are True (T) or False (F). 20) Which extraoral radiographic image is used to examine fractures of the condylar neck? A) the dentist who originally prescribed the radiographs. A) They must be able to carry out an effective quality assurance program. Let's take them again. False C) Increases radiation exposure A) Increases spatial resolution 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."). A) Radiographers must be thoroughly familiar with the operating instructions when using handheld x-ray devices. Which one is the exception? (b) The foreseeable risks to the subjects are low. Risks will differ according to the subject population. 3) Which of the following statements regarding dental x-ray machine output consistency testing is correct? Most institutions decide to apply the Common Rule to all research with human subjects, regardless of the funding source. Thus, rather than an endpoint, the consent document should be the basis for a meaningful exchange between the investigator and the subject. C) ask the receptionist for the correct pronunciation. C) Fanning The ethical principle that research participants should be told enough about a piece of research to be able to make a decision about whether to participate in it. Which research principle is this a glossary definition of? gather data from procedures or activities that are already being performed for non-research reasons C) Unless required by law, personnel monitoring devices should be discouraged. Office of the Commissioner, Office of Clinical Policy and Programs, Office of Clinical Policy, Office of Good Clinical Practice, An official website of the United States government, : ATI COMPREHENSIVE EXIT EXAM 2023 1. If a covered entity obtains or receives a valid Authorization for its use or disclosure of PHI for research, it may use or disclose the PHI for the research, but the use or disclosure must be consistent with the Authorization . a statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which . B) The patient 16) Which word is least likely to be understood by the average patient? 17) What agency sets and enforces regulations regarding safe handling of chemicals and materials and the management of potentially hazardous wastes used in dental radiography? B) Headrest Investigational drug and biologic studies are not officially approved by FDA. A) Solution levels must be replenished and changed on a regular basis. The consent process begins when a potential research subject is initially contacted. C) Cone beam computed tomography Our decisions do not influence the lives of other people. C) Take radiographs only if the dentist is present. A) Keep retake radiographs under three per patient. C) Coronal The required signatures on a short form are stated in 21 CFR 50.27(b)(2). 21 CFR 50.25 Elements of informed consent. B) Transcranial projection A) Tube-shift method And when potential outcomes are less severe, such as embarrassment, people tend to underestimate their probability. 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. D) Increases movement artifacts, 20) A CBCT examination produces as many as ________ image slices available for interpretation (including all three anatomical planes). 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. The goal of psychological research is often to create statistical uncertainty and measure methodological uncertainty. The risks of procedures relating solely to research should be explained in the consent document. The IRB should be aware that this element includes a description not only of the benefits to the subject, but to "others" as well. Thus, if these benefits may be materially relevant to the subject's decision to participate, they should be disclosed in the informed consent document. A) Chin rest To explain to you why they wish to leave so that you can conduct debriefing. 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