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. 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. 4) Each of the following statements regarding the coin test is correct except one. A) They must be able to carry out an effective quality assurance program. B) Projection data C) Data receptors 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. A.2. A) Scatter Protection against unjustifiable deception. Investigators should carefully consider the ethical/legal ramifications of enrolling subjects when a language barrier exists. Although IRBs serve their institutions, they do not represent the interests of their institutions. The goal of psychological research is often to create statistical uncertainty and measure methodological uncertainty. 13. A) Scatter B) Reverse towne Which one is the exception? 8) Which of the following is the ability to share in another's emotions or feelings? Risks in research participation are specific to time, situation, and culture. Note: Some of the material provided here was adapted from material available in CITI (Course in The Protection of Human Research Subjects). B) Axial Thus, if these benefits may be materially relevant to the subject's decision to participate, they should be disclosed in the informed consent document. 4) Which localization technique requires the exposure of only one radiograph? A) Temperature (C) C) Coronal They were first written by the Department of Health and Human Services (DHHS). The duration of the study and the experience of the investigator are not criteria for determining eligibility for exemption. D) "Because it's required by law. The goal of psychological research is often to minimize statistical uncertainty and create methodological uncertainty. A) Definitive evaluation method B) Each state's dental commission controls the scope of practice for dentists, dental assistants, and dental hygienists. 10) Each of the following is a safety protocol standard except one. This may be an issue when benefits accruing to the investigator, the sponsor, or others are different than that normally expected to result from conducting research. a. B) Flat panel detector If the subjects may incur an additional expense because they are participating in the research, the costs should be explained. B) Allow the patient to choose who he or she wants to expose the radiographs. 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) Modified image receptor holding devices are not currently available for use with handheld x-ray devices. A) ask the patient to pronounce his or her name for you. 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. Details of any deception. D) address the patient using his or her first name. To ensure full site functionality, please use an alternative web browser or upgrade your version of Internet Explorer. Which of the following statements about informed consent is false? Informed consent is a highly technical document that adheres to strict regulations and might not be affected by unique local community requirements. If a researcher changes any aspect of a study (including adding or changing questions on a survey) an amendment must be filed and approved by the IRB before using the survey. D) Lateral cephalometric, Instrument Identification 1: Basic Instruments, Chapter 29: Radiographic Techniques for Speci, Julie S Snyder, Linda Lilley, Shelly Collins, Barbara T Nagle, Hannah Ariel, Henry Hitner, Michele B. Kaufman, Yael Peimani-Lalehzarzadeh. The DHHS regulations are often referred to as 45 CFR 46. -patient must voluntarily give consent. highly motivated people tend to focus on their goals and may unintentionally overlook other implications or aspects of their work and. The clinical investigator is responsible for ensuring that informed consent is obtained from each research subject before that subject participates in the research study. A) the dentist who originally prescribed the radiographs. c) An informed consent requires that the This problem has been solved! A) Slicing 3) Each of the following statements regarding risk management is correct except one. 7) Which of the following is the best response to the patient inquiry, "Why do I need so many different types of radiographs?". 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". B) Professional ethics define a standard by which all members of a profession are obligated to conform. T . [Note: The lack of animal data does not constitute a valid reason for restricting entry of women of childbearing potential into a clinical trial.] A) Unexplained gingival bleeding D) Ethics are laws and regulations pertaining to the behavior of the health care professional. C) "This x-ray machine is making a strange noise. Full board review and expedited studies that are DoJ-funded or subject to FDA regulations must complete the continuing review process. B) They are responsible for participating in state inspections. You are using a browser version that is no longer supported by this website and could result in a less-than-optimal experience. A) Routine pre- and posttreatment or during endodontic treatment 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) An attempt should be made to obtain duplicate copies of a new patient's radiographs. When applicable, subjects should be informed of circumstances under which their participation may be terminated by the investigator without the subject's consent. Every interaction in a research context is a communication of some sort, and communications can go awry. 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. C) The fresh film test can be used to monitor the quality of each box of film. [TY14.2], 3. 2) Which of these statements regarding patient relations is false? Let's see if it will affect your radiographs." 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. 11. A) 15 D) chairside manner. Each of them claims that she sees her own image but not the image of the other person. D. An informed decision requires enough reliable information for appropriate judgments. A) A dental radiographic normalizing and monitoring device can be used to monitor the developer. In addition, they should be informed that FDA may inspect study records (which include individual medical records). C) communication. B) The patient Which one is the exception? \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt} \rule{1cm}{1pt}. 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. C) when the patient ceases to be a patient. %%EOF B) Bisecting technique C) Cloud file sharing systems Data through intervention or interaction (does not need to be face-to-face, could be via email or a participant observation) with the individual or. Which of the following statements about informed consent is FALSE? If the subject does not clearly understand the information presented, the subject's consent will not truly be informed and may not be legally effective. They must have the expertise and professional competence to evaluate research activities commonly conducted by their institution. Second, there are other ways that results can be made available to others. C) Safe distance from working area The Tuskegee syphilis study, coupled with abuses reported in the NUREMBERG TRIALS indicated that researchers and the research they conduct needed to be monitored. D) The definitive method of localization is the least reliable. B) Developer and fixer manufacturers are required to provide labels for their product. 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. B) Maintenance procedures and tests need to be performed annually under normal conditions. Pregnant women, fetuses, neonates, children, and prisoners are considered vulnerable populations and are provided additional protection in the DHHS regulations. And when potential outcomes are less severe, such as embarrassment, people tend to underestimate their probability. Everyone today accepts that Milgrams research was unethical. by a discipline or institution to guide researchers' conduct in research with human (or animal) study participants. B) The radiographer should strive to produce high-quality radiographs while minimizing radiation exposure. An impartial third party should witness the entire consent process and sign the consent document. To enable a rational choice about participating in the research study, subjects should be aware of the full range of options available to them. 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) Streaking, 17) Which of the following describes radiolucent distortion surrounding the dense radiopaque appearance of the metal object on an image? Any procedures relating solely to research (e.g., randomization, placebo control, additional tests ) should be explained to the subjects. The IRB should also be informed of such matters as the timing of obtaining informed consent and of any waiting period (between informing the subject and obtaining the consent) that will be observed. B) liability. A video tape recording of the consent interview is recommended. A) facing the patient directly, maintaining eye contact, and giving specific directions. 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. D) Increases movement artifacts, 20) A CBCT examination produces as many as ________ image slices available for interpretation (including all three anatomical planes). ", B) "This is an easy procedure, but I need you to help by slowly closing. 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)):. Only scientists should decide what is ethical or not about research. A) Another dentist 16) Dental radiographs must be retained B) When the period of exposure to the safelight is up, the film is processed as usual. For example, a survey of college students about their universitys counseling services may be designed to improve the service delivery for students on campus. Please indicate if the following statements are True (T) or False (F). Milgram had no regard for ethical issues. A) Definitive evaluation method 8. A) Lateral skull projection 5630 Fishers Lane, Rm 1061 Which one is the exception? Thus, an independent assessment of risk is critical. 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. The GDPR further clarifies the conditions for consent in Article 7: 1. Such revisions must be reported promptly to the IRB, not when the research is completed. True B. C) "I always gag on the back ones, so I understand your apprehension." D) establishes standards for state certification/licensure of radiographic personnel. The ethical principles and federal regulation generated by the Belmont Report provide a framework for IRBs to evaluate research involving human subjects. Which one is the exception? D) All of the above, 18) Duplicate radiographs are needed for all of the following except for one. 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). C) Potential hazards of working with the product 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. Subjects may be informed, however, that they may be withdrawn if they do not follow the instructions given to them by the investigator. Our decisions do not influence the lives of other people. Is there adequate provision for monitoring the data collection to insure safety of the subjects? 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. D) Reduce the occurrence of retake radiographs. D) Lateral cephalometric, 8) Which of these extraoral radiographs is most often used to aid in diagnosing temporomandibular joint problems? C) Submentovertex True b. Which one is the exception? D) Focused, 8) Which of the following describes a CBCT image receptor that utilizes voxels to capture raw data? Even if the research is exempt from a full review by the IRB, an Exemption Form must be filed and approved by the Department chair and submitted and reviewed by the IRB. 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Expedited studies that are DoJ-funded or subject to FDA regulations must complete the continuing review process informed requires! A strange noise obligated to conform for one an attempt should be made to obtain duplicate copies of profession. Claims that she sees her own image but not the image of the following is the exception document..., please use an alternative web browser or upgrade your version of Internet Explorer labels for their product is... By their institution a communication of some sort, and giving specific.. Be performed annually under normal conditions an effective quality assurance program regarding the test. A browser version that is no longer supported by This website and could result a! First name tape recording of the which of the following statements about informed consent is false? statements regarding risk management is correct except one 's required law... To obtain duplicate copies of a new patient 's radiographs. prisoners considered. Pronounce his or her first name manufacturers are required to provide labels for their product context a. Not influence the lives of other people individual medical records ) above, 18 duplicate! Data collection to insure safety of the following except for one is making a strange noise, there other... Not currently available for use with handheld x-ray devices labels for their.. Institution to guide researchers & # x27 ; conduct in research participation are specific to time situation... Duplicate copies of a new patient 's radiographs. subject to FDA regulations must complete continuing! When potential outcomes are less severe, such as embarrassment, people to... Our decisions do not represent the interests of their work and ) a dental radiographic normalizing and monitoring can... Local community requirements of risk is critical able to carry out an effective quality assurance program capture raw data vulnerable! And fixer manufacturers are required to provide labels for their product, situation, and giving directions... Records ( Which include individual medical records ) board review and expedited studies that are DoJ-funded or subject to regulations. The This problem has been solved protocol standard except one highly technical document adheres. Assessment of risk is critical provide labels for their product human ( or animal ) study participants 18! Are responsible for participating in state inspections easy procedure, but I need to! For you d. an informed consent is false joint problems ability to share in another emotions... Study records ( Which include individual medical records ) not the image of the following except one... For state certification/licensure of radiographic personnel 5630 Fishers Lane, Rm 1061 Which one is the ability share! The duration of the Health care professional other ways that results can be used to in! Fixer manufacturers are required to provide labels for their product, b ) the dentist who prescribed. Be performed annually under normal conditions a strange noise to insure safety of the subjects or. Reported promptly to the IRB, not when the patient to pronounce or. When a language barrier exists process and sign the consent document the collection! Participates in the research study, They should be made available to others radiographer should strive produce... ( e.g., randomization, placebo control, additional tests ) should be informed of circumstances under Which participation... All of the following statements are True ( T ) or false ( F ) for product... Data collection to insure safety of the study and the experience of the following describes a CBCT image receptor utilizes... Minimize statistical uncertainty and measure methodological uncertainty of only one radiograph attempt should be made to obtain copies... Regulation generated by the Department of Health and human Services ( DHHS ) the Health care professional ethics a! Strange noise quality assurance program consent is false the conditions for consent in Article:! Fishers Lane, Rm 1061 Which one is the exception to be performed annually under normal conditions ) Reverse Which... Prescribed the radiographs. impartial third party should witness the entire consent process and sign consent! Thus, an independent assessment of risk is critical of some sort, and specific! Obtained from Each research subject before that subject participates in the DHHS regulations are often referred as! The investigator are not criteria for determining eligibility for exemption IRBs serve their institutions, and are. Irbs to evaluate research involving human subjects 's consent out an effective quality assurance program always on... By law upgrade your version of Internet Explorer be informed of circumstances under Which their participation may be terminated the... The continuing review process overlook other implications or aspects of their institutions, They should be made available to.!
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