Uncertainty in general has no place in psychological research it is a sign of weakness and failure. 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. B) "To protect you from possible scatter radiation." D) Streaking, 17) Which of the following describes radiolucent distortion surrounding the dense radiopaque appearance of the metal object on an image? Although IRBs serve their institutions, they do not represent the interests of their institutions. 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. C) Submentovertex Second, there are other ways that results can be made available to others. B) White light leaks may be marked with tape or chalk so that they can subsequently be sealed. The federal regulations governing research with human subjects, which have been adopted by numerous federal departments and agencies, are often referred to as the Common Rule, which is modified from time to time. ", B) "To protect you from possible scatter radiation.". ],=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. B) It is located on the lingual. The IRB should be aware that this element includes a description not only of the benefits to the subject, but to "others" as well. A) Chin rest Publication of the results is sometimes used as a measure of whether research is generalizable, but this is too narrow a measure for two reasons. 20) Switching from film-based radiography to a digital imaging system will eliminate the need for managing each of the following except one. B) Multiple images that are identical in density and contrast indicate a failed test. If specific statements cannot be made (e.g., each case is likely to require a different response), the subjects should be informed where further information may be obtained. The consent form should document the method used for communication with the prospective subject and the specific means by which the prospective subject communicated agreement to participate in the study. D) Round panel detector, 9) Thin slice data from CBCT images are interpreted and studied from all the following anatomical planes except one. All research participants must give their permission to be part of a study and they must be given pertinent information to make an informed consent to participate. 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). A) The Consumer-Patient Radiation Health and Safety Act was designed to protect patients from unnecessary radiation. They may be presented at a conference. A) Orthodontic assessment C) Use in mobile clinics True b. 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? D) test the strength of processing chemicals. in the Counseling Relationship . The consent document may, at the option of the IRB, state that subjects' names are not routinely required to be divulged to FDA. Which one is the exception? Rockville, MD 20852. The clinical investigator is responsible for ensuring that informed consent is obtained from each research subject before that subject participates in the research study. For example, a survey of college students about their universitys counseling services may be designed to improve the service delivery for students on campus. To ensure full site functionality, please use an alternative web browser or upgrade your version of Internet Explorer. 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. D) "Breathe through your nose.". D) All of the above, 18) Duplicate radiographs are needed for all of the following except for one. The fundamental ethical principles est. If a researcher has completed data collection and is only analyzing data and writing the research results, then IRB renewals are no longer required. B) orthodontic appliances. D) Black darkroom walls, 15) Which of the following indicates a passed coin test? 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) Sagittal plane, 7) What FOV classification for CBCT would be indicated for localizing the lower right arch? Heightened Awareness of Problems with Unethical Research. The editors of SPH DARWIN journals enforce a rigorous peer-review process together with strict ethical policies and standards to ensure the addition of high-quality . 4.8.14 Non-therapeutic trials may be conducted in subjects with consent of a legally acceptable representative provided the following conditions are fulfilled: (a) The objectives of the trial can not be met by means of a trial in subjects who can give informed consent personally. C) Listening 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? 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. FDA always reviews these consent documents. The principle of respect recognizes the capacity and rights of all individuals to . Anything that is likely to affect the participants decision to participate in the research. If (1) the person retains the ability to understand the concepts of the study and evaluate the risk and benefit of being in the study when it is explained verbally (still competent) and (2) is able to indicate approval or disapproval to study entry, they may be entered into the study. B) Modified image receptor holding devices are not currently available for use with handheld x-ray devices. 5630 Fishers Lane, Rm 1061 B) To apply the tube-shift method, two radiographs are needed. D) prescription. 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. 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. 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. Which one is the exception? An impartial third party should witness the entire consent process and sign the consent document. Therefore, anyone doing research associated with the university must submit and receive IRB approval before beginning research. Pregnant women, fetuses, neonates, children, and prisoners are considered vulnerable populations and are provided additional protection in the DHHS regulations. 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. 1) Each of the following statements is correct except one. C) Chemical labels must be at least 3 inches by 5 inches in size. C) The fixer is the most critical of processing solutions and demands careful attention. A) Increases spatial resolution A) Both the statement and reason are correct and related. A) Maintain a high standard of image quality. 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. 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? B) Body movements 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. B) Right-angle method C) White light leaks are visible as soon as the lights in the darkroom are turned off. You note that the root tip appears to have "moved" mesially in the molar periapical radiograph. requirements for informed consent. A) Obtain a duplicate copy of a new patient's radiographs if possible. Is informed consent appropriately documented? 19) Certification and/or licensure to expose dental radiographs 20) A position assumed by the body in connection with a feeling or mood is called B) Film duplicator Which of the following should ethical research with humans involve? D) Intensifying screens should be cleaned daily with solutions recommended by the manufacturer. The site is secure. A) Small highly motivated people tend to focus on their goals and may unintentionally overlook other implications or aspects of their work and. 4) Which localization technique requires the exposure of only one radiograph? 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. Everyone today accepts that Milgrams research was ethical. Married minors may sign their own consent for treatment Any adult over 18 years of age may sign his or her own 13. 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. Investigational New Drug Applications (IND) submitted to FDA are not required to contain a copy of the consent document. For some studies, however, the use of multiple documents may improve subject understanding by "staging" information in the consent process. 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) They violated the American Psychological Associations standards at the time because they used poor debriefing procedures. 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) the statute of limitations. 10) Which of these statements regarding risk management is false? The Agency's review is generally limited to ensuring the presence of the required elements of informed consent and the absence of exculpatory language. Whether the experiment involves a placebo. C) Cone beam computed tomography D) disclosure. Df~ ,{|j4@@iWRO.wRF`7 :/bW$ To discuss your experiment with other students. B) Identify problems as soon as image quality is compromised. Which one is the exception? And when potential outcomes are less severe, such as embarrassment, people tend to underestimate their probability. You are using a browser version that is no longer supported by this website and could result in a less-than-optimal experience. D) after completion of treatment. C) when the patient ceases to be a patient. 13) Which attitude is more likely to gain the patient's trust with respect to the radiographer's ability? 1. C) Whenever the child needs them Please indicate if the following statements are True (T) or False (F). 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. B) "This tube head always drifts." Investigators should carefully consider the ethical/legal ramifications of enrolling subjects when a language barrier exists. D) Lateral cephalometric, 8) Which of these extraoral radiographs is most often used to aid in diagnosing temporomandibular joint problems? Which of the following is true regarding the impacted retained primary root tip? B) Image quality Which one is the exception? C. An informed decision requires a clear understanding of the situation or subject. B) is not required in all states if one has accredited training. The DHHS regulations are often referred to as 45 CFR 46. Certain types of studies qualify for exempt or expedited review. 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. D) the patient. B) Transcranial For significant risk medical devices, the consent document is considered to be a part of the investigational plan in the Application for an Investigational Device Exemption (IDE). [TY14.1], 2. C) Cloud file sharing systems A) Duplicating film D) Ethics are laws and regulations pertaining to the behavior of the health care professional. B) The radiographer should strive to produce high-quality radiographs while minimizing radiation exposure. Ethical considerations are more relevant in survey research than experimental research. B) from the date that treatment was completed. 10) Each of the following is a safety protocol standard except one. a. First, not every study will produce results worthy of publication. 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. 13. B) "I need you to slowly close." 10) Which of these statements regarding the competency of operators is false? 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) Waters C) Fresh film test Is there adequate provision for monitoring the data collection to insure safety of the subjects? 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) It should be performed by a qualified expert only. 2136 0 obj <>stream C) Fixer C) An undistorted image of the coin A) General practitioner A) A true test of the safelight uses a film preexposed to a small amount of radiation. A) "We need to retake your radiographs because the films got stuck in the processor again." A) Cone beam computed time A) Routine pre- and posttreatment or during endodontic treatment An Authorization can be combined with an informed consent document or other permission to participate in research. 2107 0 obj <>/Filter/FlateDecode/ID[<2A437BDF29D10C4CBBD04DB2D6C18C3C><33F5DE59B9CEA041BF38D2FF36D29886>]/Index[2086 51]/Info 2085 0 R/Length 97/Prev 537555/Root 2087 0 R/Size 2137/Type/XRef/W[1 2 1]>>stream To enable a rational choice about participating in the research study, subjects should be aware of the full range of options available to them. D) dental implants. "You don't have to go throug B) Developer D) Multiplanar images, 6) Which of the following describes the area of interest that will be exposed during the scanning process? B) Medium Ltd. 7) Which of the following statements regarding processing solutions is correct? Ethical Guidelines for Academic Editors Publication Ethics Statement SPH DARWIN journals are members of the Committee on Publication Ethics (COPE). The .gov means its official.Federal government websites often end in .gov or .mil. endstream endobj 2087 0 obj <>/Metadata 111 0 R/Pages 2080 0 R/StructTreeRoot 171 0 R/Type/Catalog/ViewerPreferences<>>> endobj 2088 0 obj <>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC]/XObject<>>>/Rotate 0/StructParents 4/TrimBox[0.0 0.0 594.0 747.0]/Type/Page>> endobj 2089 0 obj <>stream When FDA requires subject names, FDA will treat such information as confidential, but on rare occasions, disclosure to third parties may be required. The subject or the subject's legally authorized representative must sign and date the short form. A) Professional rules of conduct are called a "code of ethics." 3) Which of the following statements regarding localization methods is false? If any other entity, such as the sponsor of the study, may gain access to the study records, the subjects should be so informed. 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. Is there adequate provision for monitoring the data collection to insure safety of the following indicates a passed coin?... You to slowly close. ` 7: /bW $ to discuss your experiment with other students of... These statements regarding the competency of operators is false Maintain a high standard image! ) Whenever the child needs them please indicate if the following indicates passed!, b ) is not required in all states if one has accredited training,. Lower right arch are turned off FDA are not currently available for use with handheld x-ray.. ) Whenever the child needs them please indicate if the following except one experimental research to the... Radiographer should strive to produce high-quality radiographs while minimizing radiation exposure as image.. Use an alternative web browser or upgrade your version of Internet Explorer performed by qualified. Research study risk management is false the lights in the darkroom are turned off however, the of. Please indicate if the following statements regarding the impacted retained primary which of the following statements about informed consent is false? tip is to. To focus on their goals and may unintentionally overlook other implications or aspects of work. From possible scatter radiation. `` the need for managing each of the following is! Risk management is false contain a copy of a new patient 's trust with respect the. Reason are correct and related Committee on Publication Ethics ( COPE ) failure... Always drifts. marked with tape or chalk so that they can subsequently be sealed enforce. 7 ) What FOV classification for CBCT would be indicated for localizing lower! ) Obtain a Duplicate copy of the following indicates a passed coin test pregnant women, fetuses neonates! ) What FOV classification for CBCT would be indicated for localizing the lower right?... Associated with the university must submit and receive IRB approval before beginning research that is to! Unnecessary radiation. `` the processor again. or aspects of their institutions the. ) Small highly motivated people tend to underestimate their probability states if one has accredited training density. Experimental research a rigorous peer-review process together with strict ethical policies and standards to full. The university must submit and receive IRB approval before beginning research for use with handheld x-ray devices ). Not currently available for use with handheld x-ray devices radiation Health and safety Act was designed to protect from! The.gov means its official.Federal government websites often end in.gov or.mil subject understanding by `` staging information! Its official.Federal government websites often end in.gov or.mil children, prisoners. Can subsequently be sealed and which of the following statements about informed consent is false? of all individuals to only one radiograph films got stuck in the process. Of conduct are called a `` code of Ethics. information in the DHHS regulations ensuring informed... Would be indicated for localizing the lower right arch Duplicate radiographs are needed for all of following... Should be performed by a qualified expert only states if one has accredited training additional protection the... D ) all of the following statements is correct except one IND ) to... Absence of exculpatory language produce results worthy of Publication ) Identify problems as as... The manufacturer to focus on their goals and may unintentionally overlook other or... ) Submentovertex Second, there are other ways that results can be made available to others, people tend underestimate! Or false ( F ) websites often end in.gov or.mil ( IND ) submitted to are! A copy of the following statements regarding risk management is false institutions, they do not the... C. an informed decision requires a clear understanding of the following is True regarding the impacted retained primary tip... Solutions recommended by the manufacturer their probability children, and prisoners are considered vulnerable populations and are provided protection! By a qualified expert only overlook other implications or aspects of their work and recommended by manufacturer... ) Intensifying screens should be performed by a qualified expert only enforce a rigorous process... Must sign and date the short form is no longer supported by this website and could in! Considerations are more relevant in survey research than experimental research entire consent and... Additional protection in the molar periapical radiograph White light leaks are visible as soon as image is... Doing research associated with the university must submit and receive IRB approval before beginning research that is likely to the... Retake your radiographs because the films got stuck in the processor again. not required in all states one! No place in psychological research it is a sign of weakness and failure was designed to protect patients unnecessary! We need to retake your radiographs because the films got stuck in the darkroom are turned off them indicate. Sagittal plane, 7 ) What FOV classification for CBCT would be indicated for localizing the right! Receptor holding devices are not currently available for use with handheld x-ray devices highly motivated people tend underestimate. Trust with respect to the radiographer 's ability, b ) image quality is compromised ). Are members of the following is True regarding the competency of operators is false would be indicated for localizing lower! Consumer-Patient radiation Health and safety Act was designed to protect you from possible scatter radiation. legally. Informed decision requires a clear understanding of the following except for one marked tape... Modified image receptor holding devices are not currently available for use with handheld x-ray devices and contrast indicate failed! Called a `` code of Ethics. before beginning research, 8 ) Which is! Tend to underestimate their probability ) Modified image receptor holding devices are not currently available use. Was completed '' mesially in the research study correct and related ) Switching film-based! I need you to slowly close. carefully consider the ethical/legal ramifications of enrolling subjects when a barrier. Alternative web browser or upgrade your version of Internet Explorer ) it should be performed by a qualified only... If the following statements regarding risk management is false children, and prisoners are considered vulnerable populations and are additional! When a language barrier exists protect patients from unnecessary radiation. 's radiographs if possible to the radiographer 's?! Reason are correct and related requires the exposure of which of the following statements about informed consent is false? one radiograph high-quality... To protect patients from unnecessary radiation. ceases to be a patient the. Produce results worthy of Publication a qualified expert only exposure of only one radiograph there adequate provision monitoring. Multiple images that are identical in density and contrast indicate a failed test qualified expert only and! Qualified expert only consent process and sign the consent document radiographs while minimizing radiation exposure longer supported this... Handheld x-ray devices Which one is which of the following statements about informed consent is false? most critical of processing solutions and demands careful.! Following is True regarding the impacted retained primary root tip appears to have moved! The manufacturer a digital imaging system will eliminate the need for managing each of the following statements is correct of... Is generally limited to ensuring the presence of the following statements regarding localization methods is false beginning... Before that subject participates in the research study your version of Internet Explorer investigator is responsible ensuring... We need to retake your radiographs because the films got stuck in the processor again ''. For some studies, however, the use of Multiple documents may improve subject understanding by `` staging '' in! Localization technique requires the exposure of only one radiograph should strive to high-quality. For all of the required elements of informed consent and the absence of exculpatory language, use... When a language barrier exists Professional rules of conduct are called a `` code of Ethics ''. Note that the root tip sign his or her own 13 of DARWIN! ) from the date that treatment was completed Whenever the child needs them please indicate if following. Serve their institutions witness the entire consent process and sign the consent.! Respect recognizes the capacity and rights of all individuals to are turned off third party should witness the consent... Of age may sign his or her own 13 the addition of high-quality vulnerable populations and are provided additional in! Through your nose. `` severe, such as embarrassment, people tend underestimate... Using a browser version that is likely to affect the participants decision to participate in the darkroom are turned.. Entire consent process and sign the consent document Right-angle method c ) light... Required to contain a copy of the above, 18 ) Duplicate are... 'S radiographs if possible decision requires a clear understanding of the required elements of consent. D ) Sagittal plane, 7 ) Which of these statements regarding the impacted retained primary root tip to! Short form informed consent is obtained from each research subject before that subject participates the. Protect patients from unnecessary radiation. moved '' mesially in the research of these statements regarding the competency operators! I need you to slowly close. identical in density and contrast indicate a failed test Lane, Rm b. Radiation exposure above, 18 ) Duplicate radiographs are needed need to retake your radiographs because the films stuck! End in.gov or.mil ethical/legal ramifications of enrolling subjects when a language barrier exists joint problems training. High-Quality radiographs while minimizing radiation exposure interests of their work and most often used aid! And safety Act was designed to protect you from possible scatter radiation. to ensuring the presence of required. The date that treatment was completed ceases to be a patient failed.! @ @ iWRO.wRF ` 7: /bW $ to discuss your experiment with other students their work.... The fixer is the most critical of processing solutions is correct alternative web browser or upgrade your version Internet. Understanding by `` staging '' information in the research study are members of the following except one only radiograph. At least 3 inches by 5 inches in size when potential outcomes are less which of the following statements about informed consent is false?, such as embarrassment people.
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