Informed consent means that researchers should tell participants about which of the following before they agree to participate in research? C) Keep patient and occupational exposures to a minimum. D) It uses a step-wedge. B) Maintenance procedures and tests need to be performed annually under normal conditions. An Authorization can be combined with an informed consent document or other permission to participate in research. When it is anticipated that significant new findings that would be pertinent to the subject's continued participation are likely to occur during the subject's participation in the study, the IRB should determine that a system, or a reasonable plan, exists to make such notification to subjects. If the only identifier collected in the course of a study would be the signature on the consent document and the principal source of harm would be a breach of confidentiality, a waiver of documentation of informed consent should be sought. D) "A small mouth makes it difficult, but this will only be for a few seconds. %PDF-1.6 % 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. B. To ensure full site functionality, please use an alternative web browser or upgrade your version of Internet Explorer. Married minors may sign their own consent for treatment Any adult over 18 years of age may sign his or her own 13. C) Take radiographs only if the dentist is present. C) Soft tissue assessment Statements that test articles are safe or statements that the safety has been established in other studies, are not appropriate when the purpose of the study includes determination of safety. D) All of the above, 18) Which of the following best responds to this patient question: "How often should children have dental x-rays?" Statistical and methodological uncertainty are the only forms of uncertainty good researchers need to worry about. D) Evaluation of sinus cavities, 4) Which of the following is a condition classified under the Preferred category regarding CBCT examinations? Everyone today accepts that Milgrams research was unethical. 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. 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. 12) Policies and procedures used to reduce the chances a patient will file legal action against the oral health care team is known as While a translator may be helpful in facilitating conversation with a non-English speaking subject, routine ad hoc translation of the consent document should not be substituted for a written translation. A) Facial expressions A) Environmental Protection Agency (EPA) 14) Legally, radiographs are the property of A) The radiographer should praise the patient for his or her assistance with the procedure. IRBs must either have sufficient expertise among their members or seek expertise through consultation if the members are not familiar with a methodology or population under consideration. Everyone today accepts that Milgrams research was ethical. B) Body movements C) Radiograph A) Dental film D) repeating requests several times to greater facilitate comprehension. Each investigator should determine the local IRB's requirements before submitting a study for initial review. [TY14.5], 6. Thus, what may be a socially sensitive issue or topic at one time or place may not be so at another time or place. Formatting requirements are institution specific. ", B) "To protect you from possible scatter radiation.". A) Waters D) Image receptor holding devices and rectangular collimation used to reduce radiation exposure. Any substantive changes to the document made by an IRB must be submitted to FDA (by the sponsor) for review and approval. If consent is obtained the same day that the subject's involvement in the study begins, the subject's medical records/case report form should document that consent was obtained prior to participation in the research. True or False: Personally identifiable information refers to information that can be used to distinguish or trace an individual's identity, either alone or when combined with other information that is linked or linkable to a specific individual. For example, a survey of college students about their universitys counseling services may be designed to improve the service delivery for students on campus. B) Flat panel detector B) Allow the patient to choose who he or she wants to expose the radiographs. A) the dentist who originally prescribed the radiographs. Which one is the exception? C) Tube-shift method. Let's take them again.". A statement that the investigator may withdraw subjects if they do not "follow study procedures" is not appropriate. And when potential outcomes are less severe, such as embarrassment, people tend to underestimate their probability. C) both the original dentist who prescribed the radiographs and a new dentist if the patient leaves the original practice. systematic investigation (this might range from applying scientific methodology involving independent and dependent variables to an ethnographic study of a community), including research development, testing, and evaluation (this also includes pilot studies, feasibility studies, and other preliminary studies). 13) A qualified health physicist should examine the equipment for which of the following failed tests? A.2. 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) Whether the experiment involves . B) Transcranial projection [TY14.4], 5. A) facing the patient directly, maintaining eye contact, and giving specific directions. B) A patient who does not want radiographs may sign a document releasing the dentist from liability. 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. B) "To protect you from possible scatter radiation." In it he described 22 examples of research studies with controversial ethics that had been conducted by reputable researchers and published in major journals. 15. A) Slicing Decisions about research ethics are always a matter of personal choice. C) If a patient has concerns regarding x-ray exposure, the radiographer should tell the patient not to worry, everything will be okay. C) Field of view Ethical considerations are more relevant in survey research than experimental research. Is subject selection equitable (e.g., subject population included or excluded; risk of coercion in recruitment, etc.). The GDPR further clarifies the conditions for consent in Article 7: 1. 12. The explanation of risks should be reasonable and should not minimize reported adverse effects. C) Increases radiation exposure For some studies, however, the use of multiple documents may improve subject understanding by "staging" information in the consent process. B) The Federal Performance Act of 1974 was designed to protect patients from unnecessary radiation. D) When using handheld x-ray devices, the operator must take a position behind the device. C) 1,500 This requirement contains three components, each of which should be specifically addressed. Let's see if it will affect your radiographs." Article 7 also sets out further 'conditions' for . For example, we usually cannot collect data from minors without parental or guardian permission. The informed consent was approved by the Washington University School of Medicine Institutional Review Board and Ethics . D) Focused, 8) Which of the following describes a CBCT image receptor that utilizes voxels to capture raw data? B) Allow the patient to choose who he or she wants to expose the radiographs. R8Vexj Although a single contact might be able to fulfill this requirement, IRBs should consider requiring that the person(s) named for questions about research subjects' rights not be part of the research team as this may tend to inhibit subjects from reporting concerns and discovering possible problems. D) disclosure. 2136 0 obj <>stream ;E The Certificates are issued by the National Institute of Health (NIH) and may be secured for any research (even non-NIH research), regardless of the source of funding or even for un-funded research. D) Oral pathologic lesion evaluation, 5) Which of the following aspects of a traditional CT examination does not justify its use in dental applications? Which one is the exception? 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 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) Slicing They were first written by the Department of Health and Human Services (DHHS). C) may or may not be regulated by the dentist/employer. B) Identify problems as soon as image quality is compromised. 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. B) Each state's dental commission controls the scope of practice for dentists, dental assistants, and dental hygienists. Is the process for obtaining consent appropriate? To complete the experimental session because you would not ask personal questions unless they were really important for science. A) Orthodontic assessment B) Growth and development B) Working radiograph method The .gov means its official.Federal government websites often end in .gov or .mil. 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. Are risks greater than minimal risk*? See the answer Show transcribed image text Expert Answer A person who can understand and comprehend spoken English, but is physically unable to talk or write, can be entered into a study if they are competent and able to indicate approval or disapproval by other means. B) Cone beam computed tomography 9) Each of the following applies to all oral health care team members except one. requirements for informed consent. B) Use in dental forensics Heightened Awareness of Problems with Unethical Research. First, not every study will produce results worthy of publication. Investigators should ensure that the potential risks that the study poses are adequately explained to subjects who are asked to enter a study. D) The water supply must be turned on and the dryer operating correctly to produce a clear, dry film. 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. A) Duplicating film C) Fanning B) Transcranial A) a code of ethics. D) Sagittal. To enable a rational choice about participating in the research study, subjects should be aware of the full range of options available to them. All comments should be identified with the title of the guidance. B) dimension. B) Axial They led to important developments in ethical principles in psychological research. D) after completion of treatment. D) Posteroanterior projection, 9) Which of these extraoral radiographs is most often used to show the base of the skull? 12) CBCT's ability to accurately image the location of the inferior alveolar nerve and maxillary sinus is useful when treatment planning D) Round panel detector, 9) Thin slice data from CBCT images are interpreted and studied from all the following anatomical planes except one. A) Radiation dose B) They are responsible for participating in state inspections. When FDA requires subject names, FDA will treat such information as confidential, but on rare occasions, disclosure to third parties may be required. -patient must voluntarily give consent. A) Keep retake radiographs under three per patient. Therefore, the witness must be present during the entire consent interview, not just for signing the documents. Although an investigator may not recruit subjects to participate in a research study before the IRB reviews and approves the study, an investigator may query potential subjects to determine if an adequate number of potentially eligible subjects is available. A waiver of documentation of informed consent is helpful when the consent form is the only document that links the subject to the study. 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. Will only be for a few seconds been conducted by reputable researchers and published in major journals and! Who does not want radiographs may sign their own consent for treatment Any adult over years... Patient and occupational exposures to a minimum a waiver of documentation of informed consent was approved by dentist/employer! To protect patients from unnecessary radiation. `` to the study researchers should tell about... 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