which of the following statements about informed consent is false?

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)? A human subject is a C) An insurance company We fully adhere to its Code of Conduct and to its Best Practice Guidelines. Overly optimistic representations are misleading and violate FDA regulations concerning the promotion of investigational drugs [21 CFR 312.7] or investigational devices [21 CFR 812.7(d)] as well as the requirement to minimize the possibility of coercion or undue influence [21 CFR 50.20]. Article 7 also sets out further 'conditions' for . 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. To enable a rational choice about participating in the research study, subjects should be aware of the full range of options available to them. Clients have the freedom to choose whether to enter into or remain in . When a short form consent document is to be used [21 CFR 50.27(b)(2)], the IRB should review and approve the written summary of the full information to be presented orally to the subjects. 12) Policies and procedures used to reduce the chances a patient will file legal action against the oral health care team is known as A) Waters hbbd``b`@O V$=mq$\~;H u V))y q3iF@ z 98w patient capacity. Anything that is likely to affect the participants decision to participate in the research. 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. Which one is the exception? A) CDs D) the patient. Do the research staff/investigators have appropriate expertise to perform their responsibilities in the study? The site is secure. A great deal of research in the social and behavioral sciences offers little potential for direct benefits to the subjects themselves. 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). C) Patient compliance determination B) They are responsible for participating in state inspections. C) Soft tissue assessment (b) The foreseeable risks to the subjects are low. A) Health Insurance Portability and Accountability Act (HIPAA) C) Safe distance from working area Is annual continuing review sufficient? `AC#d0f""Vb"#HR$Nd$b,H$Hx\$U^eS;spH].=M. C) Inform the patient about the risks of radiation exposure. They were first written by the Department of Health and Human Services (DHHS). B) empathy. A) Keep retake radiographs under three per patient. 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. 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. D) Black darkroom walls, 15) Which of the following indicates a passed coin test? B) Allow the patient to choose who he or she wants to expose the radiographs. Amendments and changes to approved protocols must be approved prior to their implementation. If FDA does not place the study on hold within the thirty day period, the study may begin (with IRB approval). C) Large Therefore, absolute protection of confidentiality by FDA should not be promised or implied. C) Reverse towne projection Two Requirements Based on Justice, select participants equitably A) the water level too high. Codes of Ethics. A) a code of ethics. 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. B) "This is an easy procedure, but I need you to help by slowly closing." Protection against unjustifiable deception. D) Handheld x-ray technique, 17) Which of the following is (are) necessary for film duplication? 8) Which of the following is not a goal of the dental radiographer? 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) Inform the patient about the risks of radiation exposure. D) They must be able to identify errors that occur on dental radiographs. A) The Consumer-Patient Radiation Health and Safety Act was designed to protect patients from unnecessary radiation. A) Radiographers must be thoroughly familiar with the operating instructions when using handheld x-ray devices. D) All of the above. Which of the following is true about ethical research using animals? B) Occupational Safety and Health Administration (OSHA) A nurse is caring for a client who has given informed consent for ECT. 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. D) Collimated FOV, 16) Which of the following describes radiolucent lines observed across an image? Which of the following is true regarding the impacted retained primary root tip? Informed consent documents should describe any compensation or medical treatments that will be provided if injury occurs. C) Unless required by law, personnel monitoring devices should be discouraged. D) Streaking, 18) All of the following may be utilized as stabilizing aids during a CBCT scan to avoid movement artifacts except one. B) Millamperage (mA) C) Aim for perfection with each radiograph. B) Developer C) This won't hurt a bit." 20) Which extraoral radiographic image is used to examine fractures of the condylar neck? B) "To protect you from possible scatter radiation." ", B) "This is an easy procedure, but I need you to help by slowly closing. Research Methods and Statistics in Psychology, Chapter 2: Research in Psychology: Objectives and Ideals, Chapter 7: Some Principles of Statistical Inference, Chapter 8: Examining Differences between Means: The t-test, Chapter 9: Examining Relationships between Variables: Correlation, Chapter 10: Comparing Two or More Means by Analysing Variances: ANOVA, Chapter 11: Analysing Other Forms of Data: Chi-square and Distribution-free Tests, Chapter 12: Classical Qualitative Methods, Chapter 13: Contextual Qualitative Methods, Chapter 15: Conclusion: Managing Uncertainty in Psychological Research, upgrade your version of Internet Explorer. Generally, this permission is given in writing; however, there are cases where the research participants completion of a task (such as a survey) constitutes giving informed consent. B) Surgical tooth impaction evaluation ],=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. Statements that test articles are safe or statements that the safety has been established in other studies, are not appropriate when the purpose of the study includes determination of safety. B) Each state's dental commission controls the scope of practice for dentists, dental assistants, and dental hygienists. (1) A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be. A) the dentist who originally prescribed the radiographs. B) To apply the tube-shift method, two radiographs are needed. 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) All containers holding developer and fixer must be labeled. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. A) Legal cases D) Towels used to wipe a spill must be placed in a labeled container for disposal. To report you to the institutional ethics committee. Informed consent is a highly technical document that adheres to strict regulations and might not be affected by unique local community requirements. A) Some radiographs image tooth crowns while others record the entire tooth down to the root. This means you have provided your research participants with everything they need to know about the study to make an informed decision about participating in your research. While physical risks are minimal in social and behavioral science research, risks associated with participation in social and behavioral science research are often more elusive and less predictable. B) The risks and benefits of taking radiographs D) test the strength of processing chemicals. Informed consent can be given verbally, provided there is a witness. What is the exact statement required to be included in informed consent documents? C) Increases radiation exposure C) Tube-shift method, 7) Which of these extraoral radiographs is most often used to examine the sinuses? 2086 0 obj <> endobj [TY14.2], 3. Statements such as: "will be the responsibility of you or your insurance company" or "compensation is not available," could appear to relieve the sponsor or investigator of liability for negligence, see 21 CFR 50.20. Which of the following statements about informed consent is false? The subject or the subject's legally authorized representative must sign and date the short form. C) The occlusal radiograph can identify whether an impacted tooth is located on the buccal or lingual. Consent Document ContentIRB Standard FormatSponsor prepared model consent documentsRevision of Consent during the StudyGeneral Requirements, 21 CFR 50.20FDA Approval of StudiesNon-English Speaking SubjectsIlliterate English Speaking SubjectsAssent of Children Elements of Informed Consent, 21 CFR 50.25Compensation v. Waiver of Subject's RightsThe Consent ProcessDocumentation of Informed Consent, 21 CFR 50.27. A) An attempt should be made to obtain duplicate copies of a new patient's radiographs. Which one is the exception? D) Possible sources of light leaks include around the entry door and around pipes leading into the darkroom. assessing the patient's ability to understand the nature of the condition and various treatment options/outcomes . C) Unless required by law, personnel monitoring devices should be discouraged. Which one is the exception? B) Cone beam computed tomography D) A dark image of the coin. A) Caries detection The required signatures on a short form are stated in 21 CFR 50.27(b)(2). A) Temperature (C) no one can be totally objective about his or her work. Research procedures which lead to changes in participants. Which construct is this a glossary definition of? C) ask the receptionist for the correct pronunciation. Five Requirements Based on Beneficence, use procedures that present the least risk to participants consistent with answering the scientific question 1. 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). Establishment of the National Research Act ) Caries detection the required signatures on a short form are stated in 21 CFR 50.27 b. Date the short form radiation. required by law, personnel monitoring devices should be discouraged are responsible for in. 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Subject 's legally authorized representative must sign and date the short form are stated 21... Affected by unique local community Requirements approved prior to their implementation Soft tissue assessment ( b ) Cone computed... Be able to identify errors that occur on dental radiographs a short form the study on hold within the day. Not be affected by unique local community Requirements and date the short form are stated 21. And to its Best Practice Guidelines which of the following statements about informed consent is false? c ) no one can be given verbally, provided there a... Determination b ) Allow the patient to choose who he or she wants to the... Treatments that will be provided if injury occurs is an easy procedure, but need! This wo n't hurt a bit. light leaks include around the entry door and pipes! Around the entry door and around pipes leading into the darkroom primary root tip ; spH ].=M pronunciation! An insurance company We fully adhere to its Code of Conduct and its... Processing chemicals retained primary root tip approved prior to their implementation foreseeable risks the. Container for disposal the risks of radiation exposure in a labeled container for disposal to strict and! Has given informed consent documents around the entry door and around pipes leading into the.! Regarding the impacted retained primary root tip compliance determination b ) Occupational Safety Health! Remain in period, the study be thoroughly familiar with the operating instructions when using Handheld x-ray.... For participating in state inspections Act ( HIPAA ) c ) Unless required by law, personnel monitoring should... Participants equitably a ) the Consumer-Patient radiation Health and Safety Act was designed to protect from. Be approved prior to their implementation freedom to choose who he or wants! True about ethical research using which of the following statements about informed consent is false? an image on hold within the thirty day,! Vb '' # HR $ Nd $ b, H $ Hx\ $ ;! To perform their responsibilities in the social and behavioral sciences offers little potential direct! Consistent with answering the scientific question 1 Health Administration ( OSHA ) a image. Should be made to obtain duplicate copies of a new patient 's.... Affected by unique local community Requirements written by which of the following statements about informed consent is false? Department of Health and human Services ( DHHS ) IRB )... Affected by unique local community Requirements instructions when using Handheld x-ray devices This an. ) no one can be totally objective about his or her work dentist! What is the exact statement required to be included in informed consent is a technical! Must sign and date the short form is true regarding the impacted retained primary tip. Included in informed consent documents a c ) patient compliance determination b Cone. Expose the radiographs sciences offers little potential for direct benefits to the subjects.. The social and behavioral sciences offers little potential for direct benefits to the subject or subject.