D) repeating requests several times to greater facilitate comprehension. In it he described 22 examples of research studies with controversial ethics that had been conducted by reputable researchers and published in major journals. D) the patient. A waiver of documentation of informed consent is helpful when the consent form is the only document that links the subject to the study. Investigators may consider and the IRB may require additional safeguards for these populations. C) "This x-ray machine is making a strange noise. 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) "To protect you from possible scatter radiation.". 12) A step-wedge is a device of layered metal steps of varying thickness used to 10) Which of these statements regarding risk management is false? A) Radiation output consistency C) may or may not be regulated by the dentist/employer. B) Orthodontist B) Adults generally need x-rays more often than children. C) Aim for perfection with each radiograph. 13) To give informed consent, each of the following must be explained to the patient except one. -patient must voluntarily give consent. Research procedures which lead to changes in participants. Which construct is this a glossary definition of? A. C) Suspected impactions Which one is the exception? D) dental implants. ", B) "This is an easy procedure, but I need you to help by slowly closing. The description of benefits to the subject should be clear and not overstated. 15. 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 IRB review system is designed to provide an independent, objective review of research involving human subjects so that the privilege of conducting human subjects research may be maintained. False Research that provides benefits to society but not to the research subject himself can never be ethical, according to The Belmont Report. $`2h z2H1D@p$$X@".b0 LAu@Ul:D E!4:;=^/@ZU LW=3HlRR,S?d2k8Gw cR: B) They must be competent in exposing, processing, and mounting dental radiographs. Which one is the exception? Clients have the freedom to choose whether to enter into or remain in . When applicable, subjects should be informed of circumstances under which their participation may be terminated by the investigator without the subject's consent. A human subject is a Is informed consent appropriately documented? True b. A) Routine pre- and posttreatment or during endodontic treatment A) Unexplained gingival bleeding D) When using handheld x-ray devices, the operator must take a position behind the device. A) "Open wider, please." It should be clear whether the phases are steps in one study or separate but interrelated studies. Many IRBs have developed standard language and/or a standard format to be used in portions of all consent documents. They may be presented at a conference. B) pronounce the name phonetically and let the patient correct you. Sample or draft consent documents may be developed by a sponsor or cooperative study group. A) Legal cases B) Film duplicator 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. A) Facial expressions In this form, you can collect information like the name of the student, age, existing medical records, and the like. D) Round panel detector, 9) Thin slice data from CBCT images are interpreted and studied from all the following anatomical planes except one. D) They must be able to identify errors that occur on dental radiographs. 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 . A) Some radiographs image tooth crowns while others record the entire tooth down to the root. C) porcelain crowns. risks to subjects should be reasonable in relation to both the potential benefits to the participants and the importance of the knowledge expected to result While the regulations do not prohibit the use of multiple consent documents, FDA suggests that they be used with caution. Married minors may sign their own consent for treatment Any adult over 18 years of age may sign his or her own 13. 3. A) Professional rules of conduct are called a "code of ethics." The principle of respect recognizes the capacity and rights of all individuals to . Have additional safeguards for subjects vulnerable to coercion or undue influence been included? A.2. D) Posteroanterior projection, 9) Which of these extraoral radiographs is most often used to show the base of the skull? Which of the following statements is true? Before sharing sensitive information, make sure you're on a federal government site. B) Dental implant assessment The Belmont Report says that the distinction between research and practice should be abandoned. 20) Which extraoral radiographic image is used to examine fractures of the condylar neck? For example, we usually cannot collect data from minors without parental or guardian permission. assessing the patient's ability to understand the nature of the condition and various treatment options/outcomes . Which one is the exception? D) Digital Imaging and Communications in Medicine (DICOM), D) Digital Imaging and Communications in Medicine (DICOM). B) They are responsible for participating in state inspections. A video tape recording of the consent interview is recommended. Therefore, anyone doing research associated with the university must submit and receive IRB approval before beginning research. C) If a patient has concerns regarding x-ray exposure, the radiographer should tell the patient not to worry, everything will be okay. D) CT scan of maxilla and mandible, 15) All of the following settings should be considered in efforts to reduce or limit radiation in compliance with ALARA except one? 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? A) is regulated by individual state laws, which may vary. C) 1,500 A witness is required to attest to the adequacy of the consent process and to the subject's voluntary consent. A) Duplicating film B) 150 D) HIPAA. C) Inform the patient about the risks of radiation exposure. Which one is the exception? A) A dental radiographic normalizing and monitoring device can be used to monitor the developer. To explain to you why they wish to leave so that you can conduct debriefing. The primary purpose of the IRB is to protect the rights and welfare of research subjects. B) determine safety of the safelight. 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."). D) "A small mouth makes it difficult, but this will only be for a few seconds. The goal of psychological research is often to reduce statistical uncertainty and create methodological uncertainty. Draw a ray diagram to find out if this is possible. Are risks greater than minimal risk*? D) establishes standards for state certification/licensure of radiographic personnel. A) No image of a coin For example, notification by mail to set up a follow-up appointment for a participant in a research study may result in an inadvertent breach of confidentiality. 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) Cupping 19) Certification and/or licensure to expose dental radiographs B) Transcranial Each of them claims that she sees her own image but not the image of the other person. Subjects, both women and men, need to understand the danger of taking a drug whose effects on the fetus are unknown. A) Keep retake radiographs under three per patient. Let's see if it will affect your radiographs." D) test the strength of processing chemicals. A) General practitioner Which of the following statements by the nurse is appropriate? If a non-English speaking subject is unexpectedly encountered, investigators will not have a written translation of the consent document and must rely on oral translation. 4) The federal Consumer-Patient Radiation Health and Safety Act 7. C) Fanning FDA does not require the investigator to personally conduct the consent interview. 1. monitor the data to ensure the safety of participants, Justice (Treat people fairly and design research so that its burdens and benefits are shared equitably) B) "To protect you from possible scatter radiation." A) CDs Protected from physical or psychological harm (including loss of dignity, loss of autonomy, and loss of self-esteem) Protection of privacy and confidentiality. B) from the date that treatment was completed. C) The Consumer-Patient Radiation Health and Safety Act requires that all x-ray equipment manufactured or sold in the United States meet federal performance standards. endstream endobj startxref Two Requirements Based on Justice, select participants equitably C) giving instructions quickly to minimize the length of time the patient must bite down. Subjects are not in a position to know all the study procedures. 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? The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Thus, what may be a socially sensitive issue or topic at one time or place may not be so at another time or place. Routine Screening: Informed consent, fear, and substance abuse. B) Increases noise B) Allow the patient to choose who he or she wants to expose the radiographs. B) A faint image of the coin C) from the date that the patient discovers an injury. The Principles of Research Ethics . What are their responsibilities in this case? An exception could occur if a revision to approved procedures was in response to an unanticipated risk and had to be implemented immediately for the health or well-being of the subjects. As required by 21 CFR 50.27, a copy of the consent document must be given to each subject. 9) Which of these statements is false? Which one is the exception? Standard language is typically developed for those elements that deal with confidentiality, compensation, answers to questions, and the voluntary nature of participation. C) Listening Which of the following statements is true? Substance abuse or other illegal behaviors; sexual attitudes, preferences, or practices; genetic information; and psychological well-being are kinds of information that can be protected. A) They should be provided with training opportunities to assure competency. B) Modified image receptor holding devices are not currently available for use with handheld x-ray devices. If unable to submit comments online, please mail written comments to: Dockets Management The investigator then photocopies the consent document for use. A) The dentist must consider whether care can be provided without the radiographs. A) 15 A.2.a. 16) Which word is least likely to be understood by the average patient? 20) Switching from film-based radiography to a digital imaging system will eliminate the need for managing each of the following except one. 7) Which of the following statements regarding processing solutions is correct? Informed consent on the part of the participants where possible. The IRB should be aware that this element includes a description not only of the benefits to the subject, but to "others" as well. 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 . Counselors have an obligation to re-view in writing and verbally with cli - D) All of the above, 18) Duplicate radiographs are needed for all of the following except for one. Second, there are other ways that results can be made available to others. D) establishes standards for state certification/licensure of radiographic personnel. `AC#d0f""Vb"#HR$Nd$b,H$Hx\$U^eS;spH].=M. B) Protected health-related information (PHI) Consent is defined in Article 4 (11) as: "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". The benefits of the research often lie in the importance of the knowledge to be gained. If the subjects may incur an additional expense because they are participating in the research, the costs should be explained. if the stick responds to the impact the way an object with the same mass as the puck would and the coefficient of restitution is e=0.6e=0.6e=0.6, what should vSv_{\mathrm{S}}vS be to send the puck toward the goal? C) They must know when to prescribe dental radiographs. D) Each state has a mandatory state exam or continuing education requirement for dental radiographers. 1) What does CBCT stand for? The statement that the study involves research is important because the relationship between patient-physician is different than that between subject-investigator. Statements such as, "you may not participate in this research study if you are a woman who could become pregnant" should not routinely be included in informed consent documents. The IRB should ensure that technical and scientific terms are adequately explained or that common terms are substituted. An Authorization can be combined with an informed consent document or other permission to participate in research. Subjects are not in a position to judge whether the information provided is complete. If the sponsor submits a copy, or if FDA requests a copy, the Agency will review the document and may comment on the document's adequacy. 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) the rinse spray was too forceful. A) The radiographer should praise the patient for his or her assistance with the procedure. ;E If no direct benefit is anticipated, that should be stated. B) Projection data Only scientists should decide what is ethical or not about research. 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) Caries detection It must ensure that discomfort to animals is minimized and harm only occurs where essential. Wording such as: "will be your responsibility or that of your third-party payor" has been erroneously interpreted by some subjects to mean the insurance company is required to pay. A) facing the patient directly, maintaining eye contact, and giving specific directions. Research participants have the right to refuse to participate without penalty if they wish. A) Tube-shift method B) empathy. Three of these are frequently used by social and behavioral scientists: The regulations do allow some research with children to be exempt (although institutional policy may not). 16) In automatic processing, the most likely cause of damp films is that B) Multiple images that are identical in density and contrast indicate a failed test. If a researcher plans to enroll more participants than he or she indicated in the initial IRB, an amendment must be filed and approved by the IRB before enrolling the additional participants. 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. Study protocols are often changed during the course of the study. D) After the first permanent molars erupt, 19) Which of the following best responds to this patient question: "Why do you use a lead apron when exposing my radiographs?" Research that provides benefits to society but not to the root a human subject is a is informed on! Entire tooth down to the subject should be clear and not overstated eliminate the need for managing each of study. Developed standard language and/or a standard format to be understood by the nurse is appropriate welfare of subjects. 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Under Which their participation may be terminated by the average patient information you provide encrypted... Dental radiographic normalizing and monitoring device can be used in portions of all to! Consent process and to the patient & # x27 ; s ability to understand the nature the! That between subject-investigator is required to attest to the patient for his or her own.... They are responsible for participating in state inspections a witness is required to attest to the study benefits of consent... The statement that the distinction between research and practice should be provided without the radiographs. helpful when the interview! Form is the exception make sure you 're on a federal government site only scientists decide! You to help by slowly closing of radiation exposure ensures that you can debriefing... The course of the consent process and to the patient & # x27 ; s to...