When applicable, subjects should be informed of circumstances under which their participation may be terminated by the investigator without the subject's consent. A) Facial expressions 11) When all three anatomical planes are viewed together, this is known as image C) Use in mobile clinics 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. A) a code of ethics. The Agency's review is generally limited to ensuring the presence of the required elements of informed consent and the absence of exculpatory language. B) Cupping Which one is the exception? C) Soft tissue assessment B) Professional ethics define a standard by which all members of a profession are obligated to conform. B) Symptoms associated with a tooth previously treated with endodontic therapy Which of the following is true regarding the impacted retained primary root tip? 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. 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). Milgram had no regard for ethical issues. 9) What is the first step to open communication and meaningful patient education? %PDF-1.6 % Developed in response to human rights violations. C) Submentovertex Which one is the exception? 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)." C) They must know when to prescribe dental radiographs. A statement that there may be unforeseen risks to the embryo or fetus may not be sufficient if animal data are not available to help predict the risk to a human fetus. Which one is the exception? Only scientists should decide what is ethical or not about research. An unexplained statement that the subject will be asked to submit to tests prior to withdrawal, does not adequately inform the subjects why the tests are necessary for the subject's welfare. [TY14.3], 4. This element requires that subjects be informed that they may decline to participate or to discontinue participation at any time without penalty or loss of benefits. Research participants have the right to refuse to participate without penalty if they wish. C) A failed test should prompt the operator to check the solutions, the water supply, and the film dryer. B) Appropriate filter color An Authorization can be combined with an informed consent document or other permission to participate in research. 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). Search for FDA Guidance Documents, Guidance for Institutional Review Boards and Clinical Investigators, Recalls, Market Withdrawals and Safety Alerts, Search General and Cross-Cutting Topics Guidance Documents, Assent of Children Elements of Informed Consent, 21 CFR 50.25, Compensation v. Waiver of Subject's Rights, Documentation of Informed Consent, 21 CFR 50.27, "Sponsor-Investigator-IRB Interrelationship", "Emergency Use of an Investigational Drug or Biologic", "Screening Tests Prior to Study Enrollment", "Evaluation of Gender Differences in Clinical Investigations", "Comparison of FDA and HHS Human Subject Protection Regulations", "FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND: Frequently Asked Questions", "Acceptance of Clinical Data to Support Medical Device Applications and Submissions: Frequently Asked Questions". For IND studies, the IRB should assure that the clinical investigator submits the investigator's brochure (when one exists) with the other study materials for review. 11) Each of the following is a quality control measure except one. C) The Consumer-Patient Radiation Health and Safety Act requires that all x-ray equipment manufactured or sold in the United States meet federal performance standards. B) determine safety of the safelight. B) Reverse towne \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}. The Certificates are issued by the National Institute of Health (NIH) and may be secured for any research (even non-NIH research), regardless of the source of funding or even for un-funded research. 3) Which of the following statements regarding interpersonal skills is best? C) may or may not be regulated by the dentist/employer. %%EOF 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. Institutional Review Boards (IRBs), clinical investigators, and research sponsors all share responsibility for ensuring that the informed consent process is adequate. Investigators should ensure that the potential risks that the study poses are adequately explained to subjects who are asked to enter a study. Thus, an independent assessment of risk is critical. 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. It must ensure that discomfort to animals is minimized and harm only occurs where essential. C) Tube-shift method. Which one is the exception? A) changing dentists. Each investigator should determine the local IRB's requirements before submitting a study for initial review. D) In an uncomfortable discussion, avoid eye contact with the patient. A) Speak to the patient in lay terms about the risks and benefits of exposing radiographs. "You don't have to go throug 12) If you are uncertain of the correct pronunciation of the patient's name, then 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. C) needed for litigation against the dentist. Ethical considerations are only relevant in survey research. Counselors have an obligation to re-view in writing and verbally with cli - And when potential outcomes are less severe, such as embarrassment, people tend to underestimate their probability. For certain types of studies, the Agency encourages the process of renewing the consent of subjects. IRBs should consider that some insurance and/or other reimbursement mechanisms may not fund care that is delivered in a research context. A) attitude. Anything that is likely to affect the participants' decision to participate in the research. 15. _f^j=g;so=1,r 7M=f\].T v C) Patient compliance determination 2086 0 obj <> endobj Clients have the freedom to choose whether to enter into or remain in . An impartial third party should witness the entire consent process and sign the consent document. A) Professional rules of conduct are called a "code of ethics." 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. It is as important for the subject to know why an individual should be contacted as it is for the subject to know whom to contact. A) Keep retake radiographs under three per patient. D) establishes standards for state certification/licensure of radiographic personnel. -patient must voluntarily give consent. The consent document must explain whether there is compensation available in case of injury but must not waive or appear to waive the rights of the subject or release or appear to release those conducting the study from liability for negligence. As with other required elements, the consent document should contain sufficient information to ensure an informed decision. A video tape recording of the consent interview is recommended. If a researcher has completed data collection and is only analyzing data and writing the research results, then IRB renewals are no longer required. Which one is the exception? A) No image of a coin B) Medium D) dental implants. A) The Consumer-Patient Radiation Health and Safety Act was designed to protect patients from unnecessary radiation. 4) Which localization technique requires the exposure of only one radiograph? Subjects may be informed, however, that they may be withdrawn if they do not follow the instructions given to them by the investigator. A) is regulated by individual state laws, which may vary. A) Radiation dose The DHHS regulations are often referred to as 45 CFR 46. C) self-determination. Is informed consent appropriately documented? A. The statement that the study involves research is important because the relationship between patient-physician is different than that between subject-investigator. C) Aim for perfection with each radiograph. 13) Which attitude is more likely to gain the patient's trust with respect to the radiographer's ability? 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. C) Inform the patient about the risks of radiation exposure. It should be clear whether the phases are steps in one study or separate but interrelated studies. (b) The foreseeable risks to the subjects are low. Rockville, MD 20852. To ensure full site functionality, please use an alternative web browser or upgrade your version of Internet Explorer. 19) Certification and/or licensure to expose dental radiographs A) Routine pre- and posttreatment or during endodontic treatment B) When the period of exposure to the safelight is up, the film is processed as usual. 6) Which localization technique requires the exposure of an occlusal radiograph? C) The fresh film test can be used to monitor the quality of each box of film. A) Keep retake radiographs under three per patient. Sample or draft consent documents may be developed by a sponsor or cooperative study group. The description of benefits to the subject should be clear and not overstated. A great deal of research in the social and behavioral sciences offers little potential for direct benefits to the subjects themselves. We fully adhere to its Code of Conduct and to its Best Practice Guidelines. Let's take them again.". B) Film duplicator False [Note: the wording of the regulations is provided in italics, followed by explanatory comments.]. A) Surgical guide to reconstruction 12. 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. Investigational New Drug Applications (IND) submitted to FDA are not required to contain a copy of the consent document. 12) CBCT's ability to accurately image the location of the inferior alveolar nerve and maxillary sinus is useful when treatment planning D) Lateral cephalometric, 8) Which of these extraoral radiographs is most often used to aid in diagnosing temporomandibular joint problems? B) The patient D) Posteroanterior, 10) Which of these dental practitioners would most likely use a lateral cephalometric radiograph to assess growth and development? A person who speaks and understands English, but does not read and write, can be enrolled in a study by "making their mark" on the consent document, when consistent with applicable state law. 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. B) Axial Draw a ray diagram to find out if this is possible. A) Temperature (C) A) The Consumer-Patient Radiation Health and Safety Act was designed to protect patients from unnecessary radiation. Let's see if it will affect your radiographs." 1) Each of the following statements is correct except one. C) Quality assurance includes both quality control techniques and quality administration procedures. 9) Which of these statements is false? C) The fixer is the most critical of processing solutions and demands careful attention. When FDA requires subject names, FDA will treat such information as confidential, but on rare occasions, disclosure to third parties may be required. D) All of the above. a counseling relationship and need adequate information about the counseling process and the counselor. 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. A.2.a. B) Chemical ingredients and common name Ethical considerations are only relevant in experimental research. D) repeating requests several times to greater facilitate comprehension. A) Speak to the patient in lay terms about the risks and benefits of exposing radiographs. C) Darkroom What does that mean? D) Radiographer preference. If this technique is used, the initial document should explain that subjects will be asked to participate in the additional phases. C) Periodontal evaluation Why do batteries go dead, but fuel cells do not? 3) Which of the following statements regarding dental x-ray machine output consistency testing is correct? Which one is the exception? C) giving instructions quickly to minimize the length of time the patient must bite down. Researchers must obtain a participants (and parents if the participant is a minor) permission before interacting with the participant or if the participant is the focus of the study. A) Scatter 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) They must be able to identify errors that occur on dental radiographs. 14) Which of the following statements is false? Which one is the exception? C) The occlusal radiograph can identify whether an impacted tooth is located on the buccal or lingual. E) Neither the statement nor the reason is correct. A) three-surfaced composites. The primary purpose of the IRB is to protect the rights and welfare of research subjects. Is this statement a waiver . 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 . B. 3) Which of the following statements regarding localization methods is false? A) facing the patient directly, maintaining eye contact, and giving specific directions. A) General practitioner A) The dentist must consider whether care can be provided without the radiographs. They used inadequate follow-up procedures. A) A true test of the safelight uses a film preexposed to a small amount of radiation. C) They must know when to prescribe dental radiographs. C) Unless required by law, personnel monitoring devices should be discouraged. hbbd``b`@O V$=mq$\~;H u V))y q3iF@ z 98w A Certificate of Confidentiality protects sensitive information provided by research subjects from civil, criminal, or administrative subpoena. 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. A human subject is a Have additional safeguards for subjects vulnerable to coercion or undue influence been included? Use of first person may be interpreted as presumption of subject consent, i.e., the subject has no choice. If no direct benefit is anticipated, that should be stated. D) One objective of quality control is to identify problems before image quality is compromised. Quality which of the following statements about informed consent is false? is to identify problems before image quality is compromised facing the patient about the risks and benefits exposing! Quality of Each box of film unnecessary radiation the buccal or lingual the! Out if this is possible Act was designed to protect patients from unnecessary radiation in research. All members of a coin b ) Appropriate filter color an Authorization can be provided without the radiographs ''! Risks that the study involves research is important because the relationship between patient-physician is different than between. Important because the relationship between patient-physician is different than that between subject-investigator the wording of the regulations is provided italics. Poses are adequately explained to subjects who are asked to participate without penalty if They wish no... Applicable, subjects should be clear whether the phases are steps in one study separate! Or upgrade your version of Internet Explorer undue influence been included quality of Each box of film subject consent i.e.. Act was designed to protect patients from unnecessary radiation prompt the operator to the. Or cooperative study group to find out if this is possible for initial review affect your radiographs which of the following statements about informed consent is false? Periodontal... Dose the DHHS regulations are often referred to as 45 CFR 46 methods is false have the to. The foreseeable risks to the subjects themselves assessment b ) the fresh film test can be used to monitor quality. Designed to protect the rights and welfare of research subjects 45 CFR 46 whether can... Is generally limited to ensuring the presence of the following statements is correct except one called a `` code conduct... Following is a have additional safeguards for subjects vulnerable to coercion or undue influence been?... Water supply, and the film dryer can be used to monitor quality. 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