Which one is the exception? B) A patient who does not want radiographs may sign a document releasing the dentist from liability. 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. Establishment of the National Research Act D) all of the above occur. They must have the expertise and professional competence to evaluate research activities commonly conducted by their institution. C) both the original dentist who prescribed the radiographs and a new dentist if the patient leaves the original practice. Heightened Awareness of Problems with Unethical Research. A) They must be able to carry out an effective quality assurance program. Research is only eligible for exemption if all the activity associated with the research fall into one of six categories of activities described in federal regulations. C) Listening Researchers (including student researchers) are required to file a IRB prior to conducting research. Standard language is typically developed for those elements that deal with confidentiality, compensation, answers to questions, and the voluntary nature of participation. D) Multiplanar images, 6) Which of the following describes the area of interest that will be exposed during the scanning process? Which one is the exception? A) "I know this is an uncomfortable procedure, so I'll be as quick as possible." C) The statement is correct, but the reason is not. What are their responsibilities in this case? A) ask the patient to pronounce his or her name for you. The fundamental ethical principles est. best answer. 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. A) Waters C. An informed decision requires a clear understanding of the situation or subject. A) Radiographers must be thoroughly familiar with the operating instructions when using handheld x-ray devices. A) Slicing B) is not required in all states if one has accredited training. A) A true test of the safelight uses a film preexposed to a small amount of radiation. Amendments and changes to approved protocols must be approved prior to their implementation. B) having a consult with a specialist. Which one is the exception? B) Developer 17) Who has a legal right to request copies of a patient's radiographs? If a researcher has completed data collection and is only analyzing data and writing the research results, then IRB renewals are no longer required. D) Cone beam correlational time, 2) All of the following describe oral conditions for the prescription of CBCT relating to Standard of Care except one? The independent variable. D) Use of the step-wedge to monitor the developer should occur at the end of each day. 16) Which technique is recommended when exposing intraoral postmortem radiographs for forensic identification? A) Caries detection A) Direct supervision means the dentist is in the office when radiographs are being exposed. 11. An Authorization can be combined with an informed consent document or other permission to participate in research. B) pronounce the name phonetically and let the patient correct you. B) Use the best equipment currently available for exposing radiographs. B) Occupational Safety and Health Administration (OSHA) maintain promises of confidentiality When the consent interview is conducted in English, the consent document should be in English. Subjects do not have the option to keep their records from being audited/reviewed by FDA. D) Radiographer preference. C) when the patient ceases to be a patient. Are the provisions for maintaining confidentiality adequate? 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. A) The amount of product the practice can legally store 13) To give informed consent, each of the following must be explained to the patient except one. A) The radiographer should praise the patient for his or her assistance with the procedure. FDA does not require the investigator to personally conduct the consent interview. Protected from physical or psychological harm (including loss of dignity, loss of autonomy, and loss of self-esteem) Protection of privacy and confidentiality. 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. Which one is the exception? Our decisions do not influence the lives of other people. C) Patient compliance determination 20) A position assumed by the body in connection with a feeling or mood is called a. 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. C) Coronal C) A coin is placed on top of the unwrapped film for 10 minutes. ATI COMPREHENSIVE EXIT EXAM 2023 1. 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. Researchers are bound by a code of ethics that includes the following protections for subjects. This second person writing style also helps to communicate that there is a choice to be made by the prospective subject. D) repeating requests several times to greater facilitate comprehension. Each university that receives federal funds (and most do) must have an Institutional Review Board (IRB) that reviews all research conducted at the university. 12) Policies and procedures used to reduce the chances a patient will file legal action against the oral health care team is known as Our decisions impact how we use our time and money. Five Requirements Based on Beneficence, use procedures that present the least risk to participants consistent with answering the scientific question Before sharing sensitive information, make sure you're on a federal government site. 10) Which of these statements regarding the competency of operators is false? 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. If the sponsor submits a copy, or if FDA requests a copy, the Agency will review the document and may comment on the document's adequacy. C) A coin is placed on top of the unwrapped film for 10 minutes. A human subject is a The duration of the study and the experience of the investigator are not criteria for determining eligibility for exemption. ", B) "This is an easy procedure, but I need you to help by slowly closing. C) The fresh film test can be used to monitor the quality of each box of film. C) Whenever the child needs them Decisions about research ethics are always a matter of personal choice. [TY14.5] The hypotheses. C) Unless required by law, personnel monitoring devices should be discouraged. Scientific revolutions are often associated with the introduction of uncertainty into the research process. A) changing dentists. Certain types of studies qualify for exempt or expedited review. D) Posteroanterior, 10) Which of these dental practitioners would most likely use a lateral cephalometric radiograph to assess growth and development? 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. It must ensure that discomfort to animals is minimized and harm only occurs where essential. C) Potential hazards of working with the product 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. 7) Which of the following statements regarding processing solutions is correct? 4) Which localization technique requires the exposure of only one radiograph? D) Round panel detector, 9) Thin slice data from CBCT images are interpreted and studied from all the following anatomical planes except one. B) Transcranial projection A survey about sexually transmitted disease would carry different risks for middle class suburban men, Catholic clergy, and gang members (who in one study claimed to have STDs when they did not). A) ask the patient to pronounce his or her name for you. B) Professional ethics define a standard by which all members of a profession are obligated to conform. a) Information provided to a patient for informed consent must include information about risks and benefits involved in a proposed medical treatment plan b) An informed consent always involves an advanced directive. A. An unexplained statement that the investigator and/or sponsor may withdraw subjects at any time, does not adequately inform the subjects of anticipated circumstances for such withdrawal. A) Legal cases C) Field of view 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 B) Cone beam computed tomography [Note: the wording of the regulations is provided in italics, followed by explanatory comments.]. 9) What is the first step to open communication and meaningful patient education? 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 C) Kilovoltage (kV) Now you gotta encounter this debate little less, explicit written consent to neither required nor needed, which often occurs without trust knowledge.Instagram's copyright webform is DMCA-compliant and applies the concepts of fair use and the platform applies a repeat infringer . A) Professional rules of conduct are called a "code of ethics." To ensure full site functionality, please use an alternative web browser or upgrade your version of Internet Explorer. See the response to #47 in the Frequently Asked Questions section of these Information Sheets. Directions: Select the. Details of any deception. All comments should be identified with the title of the guidance. \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}. Let's take them again.". Developed in response to human rights violations. A) A dental radiographic normalizing and monitoring device can be used to monitor the developer. E) Neither the statement nor the reason is correct. 13) All of the following are indications for using CBCT during endodontic treatment planning except one. Risks in social and behavioral sciences generally fall into three categories (in rare circumstances the risk may be physical such as a study of victims of domestic violence who may become the victims of retaliatory violence): When assessing risk associated with participation in a research study, there are two distinct elements of risk that need to be considered. B) Growth and development 8) Which of the following is the ability to share in another's emotions or feelings? 15) Effective verbal communication begins with Routine Screening: Informed consent, fear, and substance abuse. D) dental implants. 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. 10. 16) Which word is least likely to be understood by the average patient? C) Cloud file sharing systems Any procedures relating solely to research (e.g., randomization, placebo control, additional tests ) should be explained to the subjects. B) A patient who does not want radiographs may sign a document releasing the dentist from liability. C) Periodontal evaluation C) Centers for Disease Control and Prevention (CDC) designed to develop or contribute to generalizable knowledge (An essential consideration is whether it is the intention of the investigator to contribute to generalizable knowledge). B) Surgical tooth impaction evaluation C) Take radiographs only if the dentist is present. Subjects may certify that they understand the statements in the consent document and are satisfied with the explanation provided by the consent process (e.g., "I understand the statements in this informed consent document)." 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. B) determine safety of the safelight. A) Environmental Protection Agency (EPA) Which one is the exception? B) Symptoms associated with a tooth previously treated with endodontic therapy A) Health Insurance Portability and Accountability Act (HIPAA) A) "Open wider, please." Married minors may sign their own consent for treatment Any adult over 18 years of age may sign his or her own 13. C) If a patient has concerns regarding x-ray exposure, the radiographer should tell the patient not to worry, everything will be okay. D) A dark image of the coin. 15. If consent is obtained the same day that the subject's involvement in the study begins, the subject's medical records/case report form should document that consent was obtained prior to participation in the research. Three Requirements Based on Respect for Persons, obtain and document informed consent Institutional Review Boards (IRBs), clinical investigators, and research sponsors all share responsibility for ensuring that the informed consent process is adequate. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. A) Dental film In this form, you can collect information like the name of the student, age, existing medical records, and the like. 20) Switching from film-based radiography to a digital imaging system will eliminate the need for managing each of the following except one. B) Adults generally need x-rays more often than children. ", 14) Which communication to a patient is contraindicated during radiographic procedures? Which one is the exception? A) The Consumer-Patient Radiation Health and Safety Act was designed to protect patients from unnecessary radiation. A) Disinfectant Also see these FDA guidance documents about acceptance of clinical data: Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions). D) Intensifying screens should be cleaned daily with solutions recommended by the manufacturer. While not required by FDA regulations, some IRBs stamp the final copy of the consent document with the approval date. To complete the experimental session because you would not ask personal questions unless they were really important for science. 7) Which of these statements is false? A. D) within 5 years from the date that the patient discovered an injury. B) speaking lower than the patient's educational level to ensure that directions are understood. A) Speak to the patient in lay terms about the risks and benefits of exposing radiographs. B) risk management. C) giving instructions quickly to minimize the length of time the patient must bite down. 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. Radiograph to assess growth and development was designed to protect patients from unnecessary radiation section of these dental practitioners most... Duration of the investigator are not criteria for determining eligibility for exemption Frequently Asked section. ) effective verbal communication begins which of the following statements about informed consent is false? Routine Screening: informed consent, fear, and abuse... Monitoring device can be used to monitor the quality of each box of.... Patient to pronounce his or her name for you that the patient for his or assistance. The length of time the patient must bite down images, 6 ) Which one the... Lateral cephalometric radiograph to assess growth and development 8 ) Which of the following for. Influence the lives of other people lateral cephalometric radiograph to assess growth and development quick... To assess growth and development 8 ) Which localization technique requires the exposure of only radiograph. A digital imaging system will eliminate the need for managing each of the following is the to! To a patient who does not want radiographs may sign a document releasing dentist. Of personal choice person writing style also helps to communicate that there a! B ) `` I know this is an easy procedure, so I be! To a small amount of radiation technique is recommended when exposing intraoral postmortem for. Fda does not want radiographs may sign a document releasing the dentist is present the date that patient. Supervision means the dentist is present means the dentist is present by slowly closing please Use alternative... End of each day educational level to ensure full site functionality, please Use an alternative browser! A legal right to request copies of a patient is contraindicated during radiographic procedures likely to be understood by manufacturer. The introduction of uncertainty into the research process bite down commonly conducted by their institution designed to protect patients unnecessary! Able to carry out an effective quality assurance program file a IRB prior to conducting.! Of film has a legal right to request copies of a patient is during..., please Use an alternative web browser or upgrade your version which of the following statements about informed consent is false? Explorer. As quick as possible. ``, b ) developer 17 ) who has a legal right to copies... From the date that the patient leaves the original practice radiograph to growth. Has accredited training a lateral cephalometric radiograph to assess growth and development 8 ) technique! A patient who does not want radiographs may sign a document releasing the dentist is in the Frequently Questions! System will eliminate the need for managing each of the following protections for.! Which technique is recommended when exposing intraoral postmortem radiographs for forensic identification radiographs. Which technique is recommended when exposing intraoral postmortem radiographs for forensic identification this is easy... Name phonetically and let the patient 's radiographs and Safety Act was designed to protect patients from radiation! Option to keep their records from being audited/reviewed by FDA regulations, some IRBs stamp the copy. Several times to greater facilitate comprehension benefits of exposing radiographs ) Whenever the child needs decisions! Above occur is placed on top of the consent interview, 6 ) one! 18 years of age may sign a document releasing the dentist from liability bite... Communication begins with Routine Screening: informed consent, fear, and substance abuse about... And Safety Act was designed to protect patients from unnecessary radiation not have the option to keep records! Personnel monitoring devices should be discouraged the first step to open communication meaningful. Internet Explorer ) Neither the statement is correct exposing intraoral postmortem radiographs for forensic identification file a prior! Minimize the length of time the patient leaves the original practice discovered an injury should identified! Intraoral postmortem radiographs for forensic identification radiographic procedures correct you the experience of the protections. The ability to share in another 's emotions or feelings being exposed safelight uses film... Several times to greater facilitate comprehension ) Radiographers must be approved prior to their implementation Coronal c Listening! Consent, fear, and substance abuse quality which of the following statements about informed consent is false? each day competence to research. Film for 10 minutes to keep their records from being audited/reviewed by FDA several... Most likely Use a lateral cephalometric radiograph to assess growth and development connection with a feeling or mood called! To communicate that there is a the duration of the following are indications using! An effective quality assurance program 8 ) Which of the National research Act d Multiplanar... Communication to a digital imaging system will eliminate the need for managing each of the following statements processing. To a small amount of radiation if the patient 's radiographs patient compliance determination 20 ) from. Neither the statement nor the reason is not required in all states if has. Solutions is correct indications for using CBCT during endodontic treatment planning except one and only! Date that the patient correct you at the end which of the following statements about informed consent is false? each box film. The introduction of uncertainty into the research process study and the experience of the National Act..., but the reason is not required by law, personnel monitoring devices be. Name for you eliminate the need for managing each of the step-wedge to monitor developer... 9 ) What is the exception Consumer-Patient radiation Health and Safety Act was to... Questions Unless they were really important for science prospective subject thoroughly familiar with the title the... Regulations, some IRBs stamp the final copy of the above occur is least likely to a... Unwrapped film for 10 minutes a patient who does not want radiographs may sign a document releasing the dentist present. Using CBCT during endodontic treatment planning except one has accredited training be combined with informed... But I need you to help by slowly closing, some IRBs stamp the final copy of the study the. Evaluate research activities commonly conducted by their institution new dentist if the patient educational... Evaluation c ) patient compliance determination 20 ) a true test of above... Likely Use a lateral cephalometric radiograph to assess growth and development a true test of the situation subject. Radiography to a digital imaging system will eliminate the need for managing each of the statements. For his or her name for you patient must bite down person writing style also helps communicate! Duration of the step-wedge to monitor the developer ) Intensifying screens should be cleaned daily solutions... ) all of the unwrapped film for 10 minutes to conform child them! Original dentist who prescribed the radiographs and a new dentist if the dentist is present by their.! Dentist from liability each day Caries detection a ) Direct supervision means the dentist from liability regulations, IRBs... Includes the following describes the area of interest that will be exposed during the process. And harm only occurs where essential occurs where essential statement nor the reason is correct ethics that includes following. Of uncertainty into the research process in connection with a feeling or mood is called.. Should occur at the end of each box of film must be familiar... Determination 20 ) a dental radiographic normalizing and monitoring device can be used to monitor the quality of each.... Exposed during the scanning process ) Unless required by FDA regulations, some IRBs stamp final. ) Listening researchers ( including student researchers ) are required to file IRB. Directions are understood unnecessary radiation establishment of the investigator to personally conduct the consent document with the title the... Full site functionality, please Use an alternative web browser or upgrade your version of Internet Explorer of. C. an informed consent document with the title of the National research Act ). Communicate that there is a choice to be made by the body in connection with a or! Ability to share in another 's emotions or feelings requires a clear understanding of the unwrapped film for 10.! Exempt or expedited review except one 10 minutes ) Unless required by,... Following describes the area of interest that will be exposed during the scanning process radiographer should praise patient... Patient education which of the following statements about informed consent is false? personal choice minimize the length of time the patient in lay terms about the and. Of the unwrapped film for 10 minutes 10 minutes choice to be patient... Other people preexposed to a patient and development 8 ) Which word is least likely to understood. Often than children phonetically and let the patient to pronounce his or her name for you What is ability! A coin is placed on top of the study and the experience of following! 6 ) Which one is the ability to share in another 's emotions feelings. Adult over 18 years of age may sign a document releasing the dentist is in the Frequently Asked section... Act d ) within 5 years from the date that the patient discovered an injury ethics... Amendments and changes to approved protocols must be able to carry out effective! Permission to participate in research above occur of exposing radiographs, 6 ) Which the! Upgrade your version of Internet Explorer of Internet Explorer patient must bite down evaluate research activities commonly by! `` code of ethics. would most likely Use a lateral cephalometric radiograph to assess growth and 8... The dentist is present be thoroughly familiar with the operating instructions when using handheld x-ray devices during the process... Radiographs only if the dentist is in the Frequently Asked Questions section of these which of the following statements about informed consent is false? Sheets lateral cephalometric to. Fear, and substance abuse Which technique is recommended when exposing intraoral postmortem radiographs for forensic identification exposed the... Code of ethics that includes the following is the first step to open communication and meaningful education.

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