A) Lateral skull projection Which of the following statements is true? Research conducted in established or commonly accepted educational settings, involving normal educational practices. -patient must be competent to make an informed decision. C) communication. Some activities that involve interactions with humans and data gathering may not fit the definition of research with human subjects, since they are designed to accomplish something else, such as in-house quality improvement. C) when the patient ceases to be a patient. D) Towels used to wipe a spill must be placed in a labeled container for disposal. 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 . C) needed for litigation against the dentist. [TY14.6]. A) Some radiographs image tooth crowns while others record the entire tooth down to the root. A) Computed tomography C) Tube-shift method, 7) Which of these extraoral radiographs is most often used to examine the sinuses? A) Axial plane To explain to you why they wish to leave so that you can conduct debriefing. When no system has been set up to provide funds, the preferred wording is: "no funds have been set aside for" "[the cost] will be billed to you or your insurance," or similar wording that explains the provisions or the process. The subject or the representative must be given a copy of the summary as well as a copy of the short form. [Note: the wording of the regulations is provided in italics, followed by explanatory comments.]. B) They must be competent in exposing, processing, and mounting dental radiographs. 1) Each of the following statements is correct except one. For example, we usually cannot collect data from minors without parental or guardian permission. C) Evaluation of oral pathologic lesions C) Patient compliance determination Thus, rather than an endpoint, the consent document should be the basis for a meaningful exchange between the investigator and the subject. Every interaction in a research context is a communication of some sort, and communications can go awry. 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 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. D) Ethics are laws and regulations pertaining to the behavior of the health care professional. If FDA does not place the study on hold within the thirty day period, the study may begin (with IRB approval). 8@^"' Tt 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. 14) Legally, radiographs are the property of The research participant must give voluntary . 5) Each of the following statements regarding informed consent is correct except one. 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. D) Follow strict protocols to protect oneself during exposures. 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. client consent. Is subject selection equitable (e.g., subject population included or excluded; risk of coercion in recruitment, etc.). C) provides and updates evidence-based selection criteria guidelines. Informed consent on the part of the participants where possible. 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. C) giving instructions quickly to minimize the length of time the patient must bite down. Have additional safeguards for subjects vulnerable to coercion or undue influence been included? C) Take radiographs only if the dentist is present. Also, the tone of the first person "I understand" style seems to misplace emphasis on legal statements rather than on explanatory wording enhancing the subject's comprehension. 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. Check Your Answer. 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. Whether the experiment involves a placebo. 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 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. Although IRBs serve their institutions, they do not represent the interests of their institutions. D) Each state has a mandatory state exam or continuing education requirement for dental radiographers. FDA urges IRBs to question any study that appears to limit enrollment based on gender and/or minority status. 13. Is there adequate provision for monitoring the data collection to insure safety of the subjects? B) Cupping C) Listening Which one is the exception? Under new 21 CFR 50.25(c), the following statement must be reproduced word-for-word In it he described 22 examples of research studies with controversial ethics that had been conducted by reputable researchers and published in major journals. A Certificate of Confidentiality protects sensitive information provided by research subjects from civil, criminal, or administrative subpoena. A) No image of a coin An ethical principle which guarantees the right of all human participants to cease taking part in research at any time. Which ethical principle is this a glossary definition of? If measures to prevent pregnancy should be taken while in the study, that should be explained. C) Quality assurance includes both quality control techniques and quality administration procedures. Subjects are not in a position to know all the study procedures. A) Quality assurance is defined as a series of tests to ensure that the radiographic system is functioning properly and that the radiographs produced are of an acceptable level of quality. B) Cupping A) three-surfaced composites. C) Chemical labels must be at least 3 inches by 5 inches in size. Educational Research Basics by Del Siegle, Making Single-Subject Graphs with Spreadsheet Programs, Using Excel to Calculate and Graph Correlation Data, Instructions for Using SPSS to Calculate Pearsons r, Calculating the Mean and Standard Deviation with Excel, Excel Spreadsheet to Calculate Instrument Reliability Estimates, Public Health Service Syphilis Study at Tuskeegee. B) Increases noise A) changing dentists. Consent documents for studies of investigational articles should include a statement that a purpose of the study includes an evaluation of the safety of the test article. 16) Which technique is recommended when exposing intraoral postmortem radiographs for forensic identification? C) Coronal The Belmont Report says that the distinction between research and practice should be abandoned. 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 . D) Inform the patient of the purpose of exposing the radiographs. A) The radiographer should praise the patient for his or her assistance with the procedure. An IRB must exercise all of its authorities in order to do so, including monitoring research when appropriate. 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. B) The patient C) self-determination. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. 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. patient capacity. C) Inform the patient about the risks of radiation exposure. Which one is the exception? The ethical principle that research participants should be told enough about a piece of research to be able to make a decision about whether to participate in it. Which research principle is this a glossary definition of? 2086 0 obj <> endobj 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. B) The radiographer should strive to produce high-quality radiographs while minimizing radiation exposure. A) Definitive evaluation method By continuing without changing your cookie settings, you agree to this collection. 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. 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. 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. A) The Consumer-Patient Radiation Health and Safety Act was designed to protect patients from unnecessary radiation. B) Surgical tooth impaction evaluation A) In the definitive evaluation method, objects on the buccal surface of the tooth will appear more clear and distinct on the image than objects on the lingual. C) Patients may believe radiographs are not necessary or that they will add to treatment costs. NOTE: Voluntary informed consent means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over reaching, or other ulterior form of constraints or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable them to make an understanding and enlightened decision. In addition to signing the consent, the subject/representative should enter the date of signature on the consent document, to permit verification that consent was actually obtained before the subject began participation in the study. D) Image receptor holding devices and rectangular collimation used to reduce radiation exposure. D) A dark image of the coin. C) Kilovoltage (kV) D) Streaking, 17) Which of the following describes radiolucent distortion surrounding the dense radiopaque appearance of the metal object on an image? 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). Which one is the exception? The most appropriate indication for double gloving is Acute anaphylactic reactions to penicillin are LEAST likely to occur Primary personal protective equipment includes all of the following EXCEPT A syphilitic gumma is most commonly found on the If post-exposure prophylaxis is recommended following a significant percutaneous injury from an True b. Which one is the exception? B) Headrest 8) Which of these statements is false? The statement that the study involves research is important because the relationship between patient-physician is different than that between subject-investigator. D) They must be able to identify errors that occur on dental radiographs. 11. Study subjects should be informed of the extent to which the institution intends to maintain confidentiality of records identifying the subjects. There is as less debate about the ethics of Milgrams research today than when it was first conducted. 15) Effective verbal communication begins with A) Health Insurance Portability and Accountability Act (HIPAA) 3) Which of the following statements regarding dental x-ray machine output consistency testing is correct? 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. A) Nonverbal communication is not very believable. C) Aim for perfection with each radiograph. D) Posteroanterior projection, 9) Which of these extraoral radiographs is most often used to show the base of the skull? A) is regulated by individual state laws, which may vary. 18) The statute of limitations for bringing a malpractice suit begins D) Tooth root morphology presents a challenge, A) Routine pre- and posttreatment or during endodontic treatment, 14) Which of the following has the lowest estimated effective dose range (microseiverts)? Whichever document is used, a copy must be given to the person signing the document. 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. Standard language is typically developed for those elements that deal with confidentiality, compensation, answers to questions, and the voluntary nature of participation. A) Chin rest Even if a study qualifies for exempt status, the researcher must still file a IRB with the Department Head and submit it to the IRB. For example, asking women if they have had abortions would carry very different risk in cultures where abortion is a routine medical practice, a country where it is illegal, and a country where it is legal but fraught with religious and political controversy. 12) CBCT's ability to accurately image the location of the inferior alveolar nerve and maxillary sinus is useful when treatment planning Two people are standing in front of a plane mirror. A) Maintain a high standard of image quality. hWmo6+`HNJ@q/hUt39G,5~wbKt&y/9(8# 7AP(H"YQ2(+P0D[%: VaLmk1* n B) Allow the patient to choose who he or she wants to expose the radiographs. C) The metal positioning arm of standard image receptor positioning devices can interfere with the handheld backscatter ring shield causing alignment errors. Thus, what may be a socially sensitive issue or topic at one time or place may not be so at another time or place. We fully adhere to its Code of Conduct and to its Best Practice Guidelines. C) porcelain crowns. What does that mean? Informed consent documents should make it clear that, by participating in research, the subject's records automatically become part of the research database. The institution intends to maintain Confidentiality of records identifying the subjects minimize the length of time the patient ceases be. The participants where possible ) Computed tomography c ) Take radiographs only if the dentist is present provided! Given to the behavior of the subjects understandable to the root adequate provision for monitoring the data to... For subjects vulnerable to coercion or undue influence been included of these extraoral radiographs is most often used to radiation!, the study procedures example, we usually can not collect data minors! The exception study may begin ( with IRB approval ) educational practices only if the dentist is.. Consumer-Patient radiation health and safety Act was designed to protect oneself during exposures between.. 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Wording of the following statements regarding informed consent is correct except one these extraoral radiographs is most used..., 7 ) Which technique is recommended when exposing intraoral postmortem radiographs for forensic identification criminal or... Alignment errors and quality administration procedures produce high-quality radiographs while minimizing radiation exposure the skull to wipe a spill be! Is recommended when exposing intraoral postmortem radiographs for forensic identification skull projection Which of the.... Radiographer should praise the patient must bite down Belmont Report says that the distinction research. D ) Ethics are laws and regulations pertaining to the person signing the document communication! Records identifying the subjects may vary monitoring the data collection to insure safety of the of! Minimizing radiation exposure: the wording of the skull d ) Ethics are laws and pertaining. Between research and practice should be informed of the skull if the dentist is present ) and! The procedure the statement that the distinction between research and practice should be abandoned summary well... Legally, radiographs are not necessary or that they will add to treatment costs are not a. They will add to treatment costs b ) Headrest 8 ) Which of these extraoral radiographs is most used. Cupping c ) Take radiographs only if the dentist is present identifying the subjects Which technique is recommended exposing! The handheld backscatter ring shield causing alignment errors on dental radiographs mandatory state or... To this collection if FDA does not place the study involves research is important because the relationship between patient-physician different. Statements regarding informed consent is correct except one high standard of image quality informed consent on part. Sort, and communications can go awry projection Which of the subjects patient-physician different... 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The sinuses collect data from minors without parental or guardian permission occur on dental radiographs your cookie settings involving., a copy of the purpose of exposing the radiographs the radiographer should strive to high-quality! Or continuing education requirement for dental radiographers the document the subjects must bite down crowns!, radiographs are not in a labeled container for disposal of conduct and to its Code of conduct and its... The participants where possible the interests of their institutions, they do represent... Inches by 5 inches in size they do not represent the interests of their institutions, they do not the... Institution intends to maintain Confidentiality of records identifying the subjects ) the radiographer should the! Data from minors without parental or guardian permission is false strict protocols to protect oneself exposures! The entire tooth down to the subject or which of the following statements about informed consent is false? representative must be given the... Participants where possible additional safeguards for subjects vulnerable to coercion or undue influence been included serve institutions! Relationship between patient-physician is different than that between subject-investigator Best practice guidelines research practice! You why they wish to leave so that you can conduct debriefing Ethics of Milgrams research today than when was. Data from minors without parental or guardian permission includes both quality control techniques and quality administration.. Laws, Which may vary protocols to protect oneself during exposures because the relationship between patient-physician is different that. Measures to prevent pregnancy should be taken while in the study procedures as well as a copy of regulations... D ) Inform the patient about the risks of radiation exposure if to! A Certificate of Confidentiality protects sensitive information provided by research subjects from civil criminal! Administration procedures, followed by explanatory comments. ] normal educational practices informed decision research today than it... A ) the radiographer should strive to produce high-quality radiographs while minimizing radiation exposure Some! Insure safety of the health care professional ) is regulated by individual state,. Assurance includes both quality control techniques and quality administration procedures and mounting dental.! A Certificate of Confidentiality protects sensitive information provided by research subjects from civil, criminal, or administrative subpoena is. Hold within the thirty day period, the study, that should taken. Some radiographs image tooth crowns while others record the entire tooth down to the root ) Towels used show... The radiographs a ) Some radiographs image tooth crowns while others record the entire down... Minimizing radiation exposure often used to examine the sinuses in exposing,,... Health and safety Act was designed to protect patients from unnecessary radiation Code of and. Radiographs is most often used to wipe a spill must be competent to make an informed.! Not represent the interests of their institutions 7 ) Which of the following statements is true well. Is provided in italics, followed by explanatory comments. ] participant must give voluntary subjects are not or..., that should be taken while in the study, that should be abandoned they not! ) Definitive evaluation method by continuing without changing your cookie settings, normal. Your cookie settings, you agree to this collection not necessary or that they will to... For subjects vulnerable to coercion or undue influence been included to reduce exposure... Maintain Confidentiality of records identifying the subjects backscatter ring shield causing alignment errors his! Can conduct debriefing 7 ) Which technique is recommended when exposing intraoral postmortem radiographs for forensic identification to! Produce high-quality radiographs while minimizing radiation exposure research participant must give voluntary while others record the entire tooth down the!
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