A) from the date that treatment was started. B) It is located on the lingual. A) the dentist who originally prescribed the radiographs. FDA also believes that an explicit statement that an IRB has approved solicitation of subjects to participate in research could mislead or unduly induce subjects. A) 5 years after the date of exposure. A) Cone beam computed time 11. D) A coin test uses a coin and a lightly exposed film to determine safelight adequacy. The informed consent was approved by the Washington University School of Medicine Institutional Review Board and Ethics . The goal of psychological research is often to reduce statistical uncertainty and create methodological uncertainty. A) Computed tomography B) Developer 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. 5. Decisions about research ethics are always a matter of personal choice. Subjects may be informed, however, that they may be withdrawn if they do not follow the instructions given to them by the investigator. When the consent interview is conducted in English, the consent document should be in English. A) Lateral skull projection A) Unexplained gingival bleeding FDA does not require the investigator to personally conduct the consent interview. B) Modified image receptor holding devices are not currently available for use with handheld x-ray devices. A. A) The amount of product the practice can legally store D) after completion of treatment. For studies that are subject to the requirements of the FDA regulations, the informed consent documents should meet the requirements of 21 CFR 50.20 and contain the information required by each of the eight basic elements of 21 CFR 50.25(a), and each of the six elements of 21 CFR 50.25(b) that is appropriate to the study. What does that mean? 5630 Fishers Lane, Rm 1061 A) Waters B) The Federal Performance Act of 1974 was designed to protect patients from unnecessary radiation. If a researcher wishes to change any of the research procedures that were approved in the approved IRB, and amendment must be filed and approved by the IRB before those changes are made. C) Potential hazards of working with the product D) All of the above, 18) Which of the following best responds to this patient question: "How often should children have dental x-rays?" Investigational drug and biologic studies are not officially approved by FDA. D) radiation health and safety. 8. Investigators should carefully consider the ethical/legal ramifications of enrolling subjects when a language barrier exists. C) porcelain crowns. 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. The Principles of Research Ethics . B) Use in dental forensics D) Endodontist, 11) Extraoral radiographs are useful for each of the following except one. If any other entity, such as the sponsor of the study, may gain access to the study records, the subjects should be so informed. C) Periodontal evaluation This requirement contains three components, each of which should be specifically addressed. [TY14.5], 6. Codes of Ethics. B) Symptoms associated with a tooth previously treated with endodontic therapy C) may or may not be regulated by the dentist/employer. Ethical considerations are more relevant in survey research than experimental research. The procedures subjects will encounter should be outlined in the consent document, or an explanation of the procedures, such as a treatment chart, may be attached to and referenced in the consent document. D. An informed decision requires enough reliable information for appropriate judgments. 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. endstream endobj startxref A) Speak to the patient in lay terms about the risks and benefits of exposing radiographs. Are the provisions for maintaining confidentiality adequate? C) Coronal C) Take radiographs only if the dentist is present. B) Working radiograph method D) is required by law in all 50 states and the District of Columbia. A) mandates safety requirements for collimation and filtration of equipment. C) 2-D panoramic radiograph E) Neither the statement nor the reason is correct. 14) Legally, radiographs are the property of B) Millamperage (mA) D) repeating requests several times to greater facilitate comprehension. C) Cone beam computed tomography D) The definitive method of localization is the least reliable. This often means making sure that responses are anonymous. What research principle is this a glossary definition of? _f^j=g;so=1,r 7M=f\].T v The following criteria are often considered by Institutional Review Boards for the Protection of Human Subjects: *minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are no greater in and of themselves from those ordinarily encountered in daily life or during the performance of routine physical or psychological examination or tests. D) establishes standards for state certification/licensure of radiographic personnel. Anything that is likely to affect the participants decision to participate in the research. Which of the following statements is true? Informed Consent . Milgram had no regard for ethical issues. 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 . The goal of psychological research is often to create statistical uncertainty and reduce methodological uncertainty. B) "To protect you from possible scatter radiation." C) Keep patient and occupational exposures to a minimum. gather data from procedures or activities that are already being performed for non-research reasons Informed consent can be given verbally, provided there is a witness. c) An informed consent requires that the This problem has been solved! C) Chemical labels must be at least 3 inches by 5 inches in size. The investigator then photocopies the consent document for use. 15. D) "Because it's required by law. D) Increases movement artifacts, 20) A CBCT examination produces as many as ________ image slices available for interpretation (including all three anatomical planes). C) Submentovertex B) Projection data 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). `+a - 0 Thus, if these benefits may be materially relevant to the subject's decision to participate, they should be disclosed in the informed consent document. Because it is such a controversial topic, the issues it raises are only worth discussing in relation to medical research. Which of the following statements is true? highly motivated people tend to focus on their goals and may unintentionally overlook other implications or aspects of their work and. D) Round panel detector, 9) Thin slice data from CBCT images are interpreted and studied from all the following anatomical planes except one. Do the research staff/investigators have appropriate expertise to perform their responsibilities in the study? D) Possible sources of light leaks include around the entry door and around pipes leading into the darkroom. A witness is required to attest to the adequacy of the consent process and to the subject's voluntary consent. However, the IRB of record is the final authority on the content of the consent documents that is presented to the prospective study subjects. [TY14.1], 2. A) A true test of the safelight uses a film preexposed to a small amount of radiation. When FDA requires subject names, FDA will treat such information as confidential, but on rare occasions, disclosure to third parties may be required. B) Reverse towne Research involving minors SELDOM qualifies for exempt status. Which of the following statements about informed consent is FALSE? 7) Which of the following is the best response to the patient inquiry, "Why do I need so many different types of radiographs?". Thus, what may be a socially sensitive issue or topic at one time or place may not be so at another time or place. ", B) "To protect you from possible scatter radiation.". by a discipline or institution to guide researchers' conduct in research with human (or animal) study participants. D) In an uncomfortable discussion, avoid eye contact with the patient. D) There are no federal laws regarding use of dental x-ray equipment. B) The risks and benefits of taking radiographs A) Chin rest C) Submentovertex C) Fixer D) Ethics are laws and regulations pertaining to the behavior of the health care professional. The statement that the study involves research is important because the relationship between patient-physician is different than that between subject-investigator. 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. D) test the strength of processing chemicals. 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. C) Radiograph The risk of emotional distress cannot be managed by anonymizing data, but rather by developing a plan to respond to the distress should it occur. 4) Each of the following statements regarding the coin test is correct except one. A) CBCT with a small FOV C) Suspected impactions Identifiable private information (a) information about behaviors that occur in a context where the individual can reasonably expect that no observations or recording is taking place or b) information that is provided for a specific purpose and for which the individual can reasonably expect will not be made public). D) Requirements for safe handling and storage, A) The amount of product the practice can legally store. B) "This is an easy procedure, but I need you to help by slowly closing." 11) Each of the following is a quality control measure except one. The clinical investigator is responsible for ensuring that informed consent is obtained from each research subject before that subject participates in the research study. C) from the date that the patient discovers an injury. C) Evaluation of oral pathologic lesions D) Material Safety Data Sheets (MSDS), B) Occupational Safety and Health Administration (OSHA), 18) Safety Data Sheets (SDS) list each of the following except one. 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 16) Which word is least likely to be understood by the average patient? 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. A) Facial expressions Is the process for obtaining consent appropriate? Informed consent documents should explain that mutagenicity (the capability to induce genetic mutations) and teratogenicity (the capability to induce fetal malformations) studies have not yet been conducted/completed in animals. A) Orthodontic assessment 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". 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. The risks of the tests required in the study protocol should be explained, especially for tests that carry significant risk of morbidity/mortality themselves. 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) When the developer solution oxidizes and deteriorates, the radiographic images darken. D) Patients may be fearful that dental x-ray exposure will be hazardous to their health. D) Black darkroom walls, 15) Which of the following indicates a passed coin test? If a researcher has completed data collection and is only analyzing data and writing the research results, then IRB renewals are no longer required. T . If the subjects may incur an additional expense because they are participating in the research, the costs should be explained. 20) Which extraoral radiographic image is used to examine fractures of the condylar neck? C) Field of view 11) When all three anatomical planes are viewed together, this is known as image 10) Each of the following is a safety protocol standard except one. B) CBCT with a large FOV An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. A) Definitive evaluation method 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. B) Adults generally need x-rays more often than children. 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? patient capacity. Which one is the exception? Informed consent means that researchers should tell participants about which of the following before they agree to participate in research? [TY14.4], 5. C) Increases radiation exposure D) They must be informed of how and why quality control tests are to be performed. B) When the period of exposure to the safelight is up, the film is processed as usual. Heightened Awareness of Problems with Unethical Research. Investigational New Drug Applications (IND) submitted to FDA are not required to contain a copy of the consent document. A) Radiation output consistency The IRB should be aware that this element includes a description not only of the benefits to the subject, but to "others" as well. B) Growth and development If FDA does not place the study on hold within the thirty day period, the study may begin (with IRB approval). Nuremberg Code - one of the 1st developed in response to Nazi atrocities in 1949. A) Maintain a high standard of image quality. A) All containers holding developer and fixer must be labeled. Investigators may consider and the IRB may require additional safeguards for these populations. The possibility of harm to participants, usually in the form of long-term negative effects. Which ethical construct is this a glossary definition of? A) three-surfaced composites. D) Intensifying screens should be cleaned daily with solutions recommended by the manufacturer. Informed consent is a highly technical document that adheres to strict regulations and might not be affected by unique local community requirements. Df~ ,{|j4@@iWRO.wRF`7 :/bW$ B) Increases noise The TUSKEGEE SYPHILIS STUDY involved 399 African-American men with latent syphilis who were not told by researchers there was a cure for the disease. This was done so the researchers could study the long-term effects of the disease. C) Patients may believe radiographs are not necessary or that they will add to treatment costs. C) State laws governing dental radiographers with on-the-job training vary considerably from state to state. Only scientists should decide what is ethical or not about research. Draw a ray diagram to find out if this is possible. D) Streaking, 18) All of the following may be utilized as stabilizing aids during a CBCT scan to avoid movement artifacts except one. An Authorization can be combined with an informed consent document or other permission to participate in research. 3) Which of the following statements regarding dental x-ray machine output consistency testing is correct? Which of the following statements by the nurse is appropriate? [TY14.5] The hypotheses. C) Quality assurance includes both quality control techniques and quality administration procedures. A) a code of ethics. C) The possible risks of refusing radiographs D) "Breathe through your nose.". -patient must voluntarily give consent. 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. Which one is the exception? A) The coin test monitors darkroom safe lighting. 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. C) Data receptors B) Use the best equipment currently available for exposing radiographs. 19) Certification and/or licensure to expose dental radiographs Sample or draft consent documents may be developed by a sponsor or cooperative study group. B) liability. C) The metal positioning arm of standard image receptor positioning devices can interfere with the handheld backscatter ring shield causing alignment errors. Which one is the exception? The description of benefits to the subject should be clear and not overstated. Everyone today accepts that Milgrams research was ethical. Note that the FDA regulations do not require the subject's copy to be a signed copy, although a photocopy with signature(s) is preferred. a counseling relationship and need adequate information about the counseling process and the counselor. A) "We need to retake your radiographs because the films got stuck in the processor again." C) The statement is correct, but the reason is not. D) Periapical, 17) Which of the following are considered forms of nonverbal communication? D) Posteroanterior, 10) Which of these dental practitioners would most likely use a lateral cephalometric radiograph to assess growth and development?
