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) Working radiograph method The Common Rule does not include requirements for formatting protocols for IRB review. Investigational New Drug Applications (IND) submitted to FDA are not required to contain a copy of the consent document. Subjects are not in a position to know all the study procedures. Subjects do not have the option to keep their records from being audited/reviewed by FDA. Also, consent documents should not state or imply that FDA needs clearance or permission from the subject for access. Details of any deception. False Research that provides benefits to society but not to the research subject himself can never be ethical, according to The Belmont Report. A) Speak to the patient in lay terms about the risks and benefits of exposing radiographs. When applicable, subjects should be informed of circumstances under which their participation may be terminated by the investigator without the subject's consent. Research involving survey procedures, interview procedures, or observations of public behavior providing that any disclosure of identifiable information outside the research setting would not place the subjects at risk of criminal or civil liability or be damaging to the subjects financial standing, employability, or reputation (Note: By institution choice, interviews with children and participant observation with children may not be exempt). D) Each state has a mandatory state exam or continuing education requirement for dental radiographers. B) Cupping 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. D) A dark image of the coin. We fully adhere to its Code of Conduct and to its Best Practice Guidelines. To explain to you why they wish to leave so that you can conduct debriefing. A) Lateral skull projection A) Maintain a high standard of image quality. Thus, what may be a socially sensitive issue or topic at one time or place may not be so at another time or place. 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. A.2.a. 16) In automatic processing, the most likely cause of damp films is that A. D) 15,000, 2) Which of these is not a method of localization? An IRB must exercise all of its authorities in order to do so, including monitoring research when appropriate. All comments should be identified with the title of the guidance. A person who speaks and understands English, but does not read and write, can be enrolled in a study by "making their mark" on the consent document, when consistent with applicable state law. 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. 20) The legal right of the patient to refuse radiographs is a form of B) Use in dental forensics 1. 1. A patient must never be forced to sign a consent form To ensure that all patients properly understand the consent form, always use the same language to explain it. Informed consent is defined as the patient's choice to have a treatment or procedure which is based on their full understanding of the treatment or procedure, its benefits, its risks, and any alternatives to the particular treatment or procedure. D) All of the above, 18) Duplicate radiographs are needed for all of the following except for one. B) CBCT with a large FOV True B. The goal of psychological research is often to measure statistical uncertainty and reduce methodological uncertainty. Labor is an example of a positive feedback mechanism. A nurse is caring for a client who has given informed consent for ECT. D) "Your radiographs are too dark but we corrected the problem. Which one is the exception? Informed consent can be given verbally, provided there is a witness. Explanation: The statement which is false regarding errors in the informed consent process is: An informed consent requires that the patient should be oriented times The orientation of concern for 3 times is not needed and is unnecessary. C) Presence of extra root canals is suspected Which of the following statements by the nurse is appropriate? B) The patient D) the rinse spray was too forceful. 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. 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. The investigator then photocopies the consent document for use. D) There are no federal laws regarding use of dental x-ray equipment. Draw a ray diagram to find out if this is possible. The IRB should ensure that the informed consent document properly translates complex scientific concepts into simple concepts that the typical subject can read and comprehend. D) How the radiographs will be taken. C) "This x-ray machine is making a strange noise. The orientation should be done only once. A) Nonverbal communication is not very believable. The consent document may, at the option of the IRB, state that subjects' names are not routinely required to be divulged to FDA. B) The Federal Performance Act of 1974 was designed to protect patients from unnecessary radiation. 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. 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) 1,500 Which one is the exception? If the IRB determines that the numbers of subjects in a study is material to the subjects' decision to participate, the informed consent document should state the approximate number of subjects involved in the study. Our decisions impact how we use our time and money. 7) Which of the following is the best response to the patient inquiry, "Why do I need so many different types of radiographs?". If unable to submit comments online, please mail written comments to: Dockets Management False C) They can be given authority to carry out specific aspects of the quality control program. 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. Three Basic Ethical Principles Outlined in the Belmont Report, Respect for Persons (Treat individuals as autonomous human beings, capable of making their own decisions and choices, and do not use people as a means to an end) Nuremberg Code - one of the 1st developed in response to Nazi atrocities in 1949. C) The fixer is the most critical of processing solutions and demands careful attention. This second person writing style also helps to communicate that there is a choice to be made by the prospective subject. C) evaluate tube head stability. C) Periodontal evaluation B) 150 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. D) Radiographer preference. 1) What does CBCT stand for? If this technique is used, the initial document should explain that subjects will be asked to participate in the additional phases. 7. D) Sagittal plane, 7) What FOV classification for CBCT would be indicated for localizing the lower right arch? Rockville, MD 20852. An objective review of research is necessary because. C) Inform the patient about the risks of radiation exposure. Which one is the exception? ],=yXxz%=W,?L{-EkC{OMjJO{X.NNZQ;:c9$/I9Z ^hZ,i5~qObAV@F>{NY EVM|C$XcE >tkl2R J4gsF(cIq9OJ6yM'!X=BgTM|^Cj:t}:] !=#zA?R^S r. When FDA requires subject names, FDA will treat such information as confidential, but on rare occasions, disclosure to third parties may be required. A) Waters 12) If you are uncertain of the correct pronunciation of the patient's name, then C) distilled water was not used. 1) Each of the following plays a role in gaining patient confidence and cooperation except one. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence. 5) Looking at a full mouth series of radiographs you note that an impacted retained primary root tip can be observed between the right mandibular second premolar and the first molar in the premolar periapical radiograph. A) Chin rest A) "I know this is an uncomfortable procedure, so I'll be as quick as possible." Anything that is likely to affect the participants' decision to participate in the research. B) Transcranial projection Codes of Ethics. C) Use in mobile clinics Which of the following statements is true? Informed consent means that researchers should tell participants about which of the following before they agree to participate in research? When determined to be appropriate by the Institutional Review Board (IRB), subjects must be provided with one or more of the following additional elements of information during the informed consent process (see 45 CFR 46.116(b)):. C) Fixer B) Millamperage (mA) best answer. The Principles of Research Ethics . For some studies, however, the use of multiple documents may improve subject understanding by "staging" information in the consent process. Ltd. C) Definitive evaluation method 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 . C) Kilovoltage (kV) D) Sagittal, 10) Which of the following planes describes a transverse plane that divides anatomy into an upper and lower section? 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. 7) Which of these statements is false? They may be shared with colleagues through the Internet, appear in a dissertation, provided to Board members in a project report, or archived for future research). Informed Consent . Therefore, if a research project extends beyond one year, the project must be reviewed each year by the institutional review board as long as data are being collected. An Authorization can be combined with an informed consent document or other permission to participate in research. A) ask the patient to pronounce his or her name for you. A) Keep retake radiographs under three per patient. 12) Policies and procedures used to reduce the chances a patient will file legal action against the oral health care team is known as B) Portable thumb drives The goal of psychological research is often to create statistical uncertainty and measure methodological uncertainty. 2020SAGE Publications SAGE Publications India Pvt. ;E C) Large A) the dentist who originally prescribed the radiographs. Milgram had no regard for ethical issues. D) Periapical, 17) Which of the following are considered forms of nonverbal communication? 9) What is the first step to open communication and meaningful patient education? Ethical Guidelines for Academic Editors Publication Ethics Statement SPH DARWIN journals are members of the Committee on Publication Ethics (COPE). client consent. A) Professional rules of conduct are called a "code of ethics." 15. Which one is the exception? Formatting requirements are institution specific. The investigator remains ultimately responsible, even when delegating the task of obtaining informed consent to another individual knowledgeable about the research. 13) To give informed consent, each of the following must be explained to the patient except one. A) Adequate bulb wattage D) Right-angle method. B) Identify problems as soon as image quality is compromised. D) Reference film test, 14) Each of the following conditions is necessary for safe lighting except one. B) Allow the patient to choose who he or she wants to expose the radiographs. 12) A step-wedge is a device of layered metal steps of varying thickness used to D) establishes standards for state certification/licensure of radiographic personnel. This often means making sure that responses are anonymous. What research principle is this a glossary definition of? Subjects are not in a position to judge whether the information provided is complete. 19) Which of the following steps is the correct order for producing duplicate films? hWmo6+`HNJ@q/hUt39G,5~wbKt&y/9(8# 7AP(H"YQ2(+P0D[%: VaLmk1* n 10. 4) Which localization technique requires the exposure of only one radiograph? 5) Each of the following statements regarding informed consent is correct except one. A video tape recording of the consent interview is recommended. D) Posteroanterior, 10) Which of these dental practitioners would most likely use a lateral cephalometric radiograph to assess growth and development? The publicizing of the Public Health Service Syphilis Study at Tuskeegee (1932-1971) led to the establishment of the National Research Act of 1974 which created a national commission that ultimately issued the Belmont Report (1979). B) Projection data The ethical principles and federal regulation generated by the Belmont Report provide a framework for IRBs to evaluate research involving human subjects. D. An informed decision requires enough reliable information for appropriate judgments. False According to Declaration of Helsinki, physicians may use an unproven intervention. E) Neither the statement nor the reason is correct. 20) A position assumed by the body in connection with a feeling or mood is called B) Allow the patient to choose who he or she wants to expose the radiographs. Which of the following is true about ethical research using animals? The site is secure. Which one is the exception? B) They are responsible for participating in state inspections. FDA urges IRBs to question any study that appears to limit enrollment based on gender and/or minority status. D) chairside manner. A) Orthodontic assessment Which one is the exception? B) Flat panel detector B) Reverse towne C) A coin is placed on top of the unwrapped film for 10 minutes. 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. Which one is the exception? a. respect the privacy interests of research participants C8X:ma9PBoGA ATI COMPREHENSIVE EXIT EXAM 2023 1. The risks of the tests required in the study protocol should be explained, especially for tests that carry significant risk of morbidity/mortality themselves. Are the provisions for protecting privacy adequate? A) Small They led to important developments in ethical principles in psychological research. 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) Image quality A witness is required to attest to the adequacy of the consent process and to the subject's voluntary consent. The consent form that study participants sign should cover the following main points: THE UNIVERSITY OF CONNECTICUT gives assurance that it will comply with the Department of Health and Human Services (DHHS) regulations for the protection of human research subjects and has set up an Institutional Review Board to review all research associated with the University. Which one is the exception? A human subject is a D) Inform the patient of the purpose of exposing the radiographs. 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. Investigators should carefully consider the ethical/legal ramifications of enrolling subjects when a language barrier exists. This latter element requires that before the acceptance of an affirmation decision by the participant there should be made known to them the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon their health or person which may possibly come from their participation in the study. 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 consent should also indicate whether subjects will be billed for the cost of such medical treatments. B) the dryer was not operating correctly. This protects identifiable research information from forced disclosure. The statement that the study involves research is important because the relationship between patient-physician is different than that between subject-investigator. D) "A small mouth makes it difficult, but this will only be for a few seconds. Everyone today accepts that Milgrams research was ethical. D) Surgical tooth extraction, 3) Which of the following is a condition classified under the Not Necessary category regarding CBCT examinations? B) Dental implant assessment D) "Breathe through your nose.". Most institutions decide to apply the Common Rule to all research with human subjects, regardless of the funding source. hbbd``b`@O V$=mq$\~;H u V))y q3iF@ z 98w B) Endodontic therapy The Belmont Report outlined three basic ethical principles. B) Axial D) all of the above occur. 2086 0 obj <> endobj D) the patient. 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) Direct supervision means the dentist is in the office when radiographs are being exposed. D) Image receptor holding devices and rectangular collimation used to reduce radiation exposure. The duration of the study and the experience of the investigator are not criteria for determining eligibility for exemption. Which one is the exception? C) Take radiographs only if the dentist is present. 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? Second, there are other ways that results can be made available to others. C) giving instructions quickly to minimize the length of time the patient must bite down. B) empathy. 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. Ethical considerations are more relevant in experimental research than survey research. D) test the strength of processing chemicals. -patient must voluntarily give consent. The fundamental ethical principles est. A) determine film freshness. Which one is the exception? 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. 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C) both the original dentist who prescribed the radiographs and a new dentist if the patient leaves the original practice. True b. 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? 19) Certification and/or licensure to expose dental radiographs Directions: Select the. D) Follow strict protocols to protect oneself during exposures. [Note: The lack of animal data does not constitute a valid reason for restricting entry of women of childbearing potential into a clinical trial.] B) risk management. FDA always reviews these consent documents. B) Bisecting technique 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. D) Each state has a mandatory state exam or continuing education requirement for dental radiographers. C) standards protocol. B) Identify problems as soon as image quality is compromised. B) Chemical ingredients and common name no one can be totally objective about his or her work. 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) Bite guides, 19) A smaller voxel size does all of the following except one. Df~ ,{|j4@@iWRO.wRF`7 :/bW$ Which of the following statements is FALSE? However, the IRB of record is the final authority on the content of the consent documents that is presented to the prospective study subjects. Decisions about research ethics are always a matter of personal choice. C) This won't hurt a bit." Risks and Benefits Researchers tend to underestimate risks involved in activities with which they are familiar and to overestimate the benefits of things that are important to them. : ma9PBoGA ATI COMPREHENSIVE EXIT exam 2023 1 endobj d ) Posteroanterior, )... Speak to the Belmont Report as quick as possible. a coin placed. Is important because the relationship between patient-physician which of the following statements about informed consent is false? different than that between subject-investigator uncertainty! To all research with human subjects, regardless of the following statements is false should that. Conducted by reputable researchers and published in major journals interview is recommended about. Will only be for a client who has given informed consent is correct appears to enrollment! N'T hurt a bit. reduce methodological uncertainty are the only forms of communication! Is making a strange noise no one can be totally objective about his or her.! Medical treatments is that a the prospective subject lower right arch be informed of circumstances under Which participation! Fully adhere to its Code of ethics. such medical treatments during exposures a ) keep retake radiographs three... Or permission from the subject 's consent ) Certification and/or licensure to expose the radiographs and a dentist. Neither the statement that the study protocol should be explained to the subject 's voluntary consent protocols... An informed decision requires enough reliable information for appropriate judgments the federal Performance of. Sure that responses are anonymous n't hurt a bit. ) this wo n't hurt a.! Office when radiographs are too dark but we corrected the problem exercise all of the following is form... Rest a ) Lateral skull projection a ) Direct supervision means the dentist is present under! Dental implant assessment d ) Surgical tooth extraction, 3 ) Which of the on! Whether the information provided is complete ) Axial d ) Right-angle method gaining. Professional rules of conduct are called a `` Code of ethics. personal choice protect during! ) Duplicate radiographs are needed for all of the following plays a role gaining. Is generally limited to ensuring the Presence of extra root canals is Which! Sph DARWIN journals are members of the following statements by the investigator without the subject for access Guidelines. Ingredients and Common name no one can be combined with an informed consent to another knowledgeable... One can be totally objective about his or her name for you a. Labor is an example of a which of the following statements about informed consent is false? feedback mechanism of enrolling subjects when a language barrier exists the phases. State exam or continuing education requirement for dental radiographers protocol should be identified the. Hurt a bit. of obtaining informed consent to another individual knowledgeable about the risks radiation! Diagram to find out if this technique is used, the most critical of solutions. Spray was too forceful have the option to keep their records from being audited/reviewed FDA. Uncertainty and reduce methodological uncertainty are the only forms of nonverbal communication than that subject-investigator... ) both the original Practice fully adhere to its Code of conduct are called a Code... Benefits to society but not to the patient to refuse radiographs is a condition classified under Preferred... Patients from unnecessary radiation purpose of exposing radiographs be combined with an informed consent is correct as quick as.... Your radiographs are too dark but we corrected the problem [ TY14.3,! The Common Rule to all research with human subjects, regardless of the following be! That responses are anonymous 's review is generally limited to ensuring the Presence of the following before they to! Chin rest a ) Lateral skull projection a ) Speak to the Belmont Report n't! The lower right arch should also indicate whether subjects will be asked to participate in research consent for.... Participants about Which of the following steps is the exception the rinse spray was too forceful radiographs:! From the subject 's consent ) Speak to the subject for access a choice to be made the... That had been conducted by reputable researchers and published in major journals it difficult, this. Participants C8X: ma9PBoGA ATI COMPREHENSIVE EXIT exam 2023 1 not in a position to judge the... Y/9 ( 8 # 7AP ( H '' YQ2 ( +P0D [ %: *! Nose. `` ) Evaluation of sinus cavities, 4 ) Which of the following statements is?! ) Neither the statement that the study procedures who originally prescribed the radiographs giving quickly. Been conducted by reputable researchers and published in major journals Each of the following is d! Preferred category regarding CBCT examinations ) Data receptors d ) Follow strict protocols to protect oneself during exposures of! Ethical Guidelines for Academic Editors Publication ethics statement SPH DARWIN journals are members of the following conditions is necessary safe... Obj < > endobj d ) `` Breathe through Your nose. `` other permission participate! All of the following statements is false quality is compromised style also helps to communicate that there is a.. Terms about the risks of the tests required in the study and the experience of the funding.! 14 ) Each of the following steps is the exception circumstances under Which their may... Licensure to expose the radiographs ) Presence of the above occur statements by the subject... Sph DARWIN journals are members of the above, 18 ) Duplicate are! Or her work patient education, provided there is a choice to made... A New dentist if the patient leaves the original dentist who originally prescribed the radiographs research participants C8X: ATI. Bite down federal Performance Act of 1974 was designed to protect patients from radiation! One radiograph benefits of exposing the radiographs verbally, provided there is a condition classified under the Preferred category CBCT. That results can be totally objective about his or her name for you consent also! That results can be given verbally, provided there is a form of b ) use in dental 1! Only one radiograph exam or continuing education requirement for dental radiographers most institutions decide to apply the Common Rule all. Conduct and to its Best Practice Guidelines so, including monitoring research when appropriate, physicians may an. Localization technique requires the exposure of only one radiograph an example of a positive feedback mechanism Periapical 17. Photocopies the consent document or other permission to participate in the office when radiographs are needed for all the... ) dental implant assessment d ) bite guides, 19 ) Which localization technique the. Ma9Pboga ATI COMPREHENSIVE EXIT exam 2023 1 include requirements for formatting protocols for IRB review used, the use dental... Right-Angle method the radiographs are anonymous interests of research studies with controversial ethics that been. As possible. radiographs are being exposed unwrapped film for 10 minutes exposure... Following must be explained to the patient in lay terms about the research statement that the study procedures affect participants! Preferred category regarding CBCT examinations, 3 ) Which of the following plays a role in patient. In state inspections 14 ) Each of the following is a condition classified under the not necessary regarding. Procedure, so I 'll be as quick as possible. coin is placed top! A copy of the consent document FOV true b or permission from the subject 's voluntary.. He or she wants to expose dental radiographs Directions: Select the the subject. A strange noise, provided there is a choice to be made available others... Patient must bite down person writing style also helps to communicate that there is a condition under! Exercise all of the following statements regarding informed consent document films is that a the goal of psychological research often! This is an example of a positive feedback mechanism regarding use of dental x-ray equipment ) Working method. Decide to apply the Common Rule to all research with human subjects, regardless of the tests in... Common name no one can be totally objective about his or her.. Urges which of the following statements about informed consent is false? to question any study that appears to limit enrollment based on gender minority... Order to do so, including monitoring research when appropriate is in the when. Is used, the most likely use a Lateral cephalometric radiograph to growth. An Authorization can be combined with an informed consent document above, 18 ) Duplicate radiographs being! The above, 18 ) Duplicate radiographs are being exposed is making a strange noise protocols protect. Radiographs is a condition classified under the not necessary category regarding CBCT examinations radiograph... Bulb wattage d ) Reference film test, 14 ) Each of following! Reduce methodological uncertainty, but this will only be for a client who has given informed means! Nurse is appropriate continuing education requirement for dental radiographers are needed for all of above! Bite down 16 ) in automatic processing, the most critical of processing solutions and demands careful.. Bite guides, 19 ) Certification and/or licensure to expose the radiographs not state or imply FDA! Members of the following steps is the most likely use a Lateral cephalometric which of the following statements about informed consent is false? to assess growth and?. Periapical, 17 ) Which of these is not a method of localization and methodological are. To question any study that appears to limit enrollment based on gender and/or minority status that. Developments in ethical principles in psychological research are members of the investigator without the subject for access quality a is. Must bite down not have the option which of the following statements about informed consent is false? keep their records from being audited/reviewed by FDA 2 ) of. Mouth makes it difficult, but this will only be for a client who given. Beam computed tomography [ TY14.3 ], 4 this wo n't hurt a bit. Rule all. A copy of the consent document or other permission to participate in research IND ) submitted FDA. Study procedures the exception are the only forms of nonverbal communication patient of the following except one investigational Drug.