15) Effective verbal communication begins with Which one is the exception? True B. C) Take radiographs only if the dentist is present. 14) Legally, radiographs are the property of Although IRBs serve their institutions, they do not represent the interests of their institutions. D) Bite guides, 19) A smaller voxel size does all of the following except one. 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. The site is secure. The investigator remains ultimately responsible, even when delegating the task of obtaining informed consent to another individual knowledgeable about the research. 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. C) A coin is placed on top of the unwrapped film for 10 minutes. Therefore, subjects are likely to impute a greater involvement by the Agency in a research study than actually exists if phrases such as, "FDA has given permission" or "FDA has approved" are used in consent documents. B) Occupational Safety and Health Administration (OSHA) For example, notification by mail to set up a follow-up appointment for a participant in a research study may result in an inadvertent breach of confidentiality. The IRB should be aware that this element includes a description not only of the benefits to the subject, but to "others" as well. Protected from physical or psychological harm (including loss of dignity, loss of autonomy, and loss of self-esteem) Protection of privacy and confidentiality. and then select . B) liability. B) Portable thumb drives A) is regulated by individual state laws, which may vary. Is the process for obtaining consent appropriate? He noted that unethical or questionable ethical procedures are not uncommon. Beechers article played an important role in heightening the awareness of researchers, the public, and the press to the problem of unethical human subjects research. The statement that the study involves research is important because the relationship between patient-physician is different than that between subject-investigator. A) Environmental Protection Agency (EPA) 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. Identifiable private information (a) information about behaviors that occur in a context where the individual can reasonably expect that no observations or recording is taking place or b) information that is provided for a specific purpose and for which the individual can reasonably expect will not be made public). Our decisions do not influence the lives of other people. The publicizing of the Public Health Service Syphilis Study at Tuskeegee (1932-1971) led to the establishment of the National Research Act of 1974 which created a national commission that ultimately issued the Belmont Report (1979). 9. 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). \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 description of benefits to the subject should be clear and not overstated. D) Digital Imaging and Communications in Medicine (DICOM), D) Digital Imaging and Communications in Medicine (DICOM). 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. Subjects are not in a position to know all the study procedures. Researchers are bound by a code of ethics that includes the following protections for subjects. 4) Each of the following statements regarding the coin test is correct except one. 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. B) Right-angle method D) Sagittal plane, 7) What FOV classification for CBCT would be indicated for localizing the lower right arch? When a sponsor submits a study to FDA as part of the initial application for an investigational new drug (IND), FDA has thirty days to review the application and place the study on "hold" if there are any obvious reasons why the proposed study should not be conducted. 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. B) A faint image of the coin B) Working radiograph method In the case of non-English speaking subjects, this would be the translated document. Draw a ray diagram to find out if this is possible. c) An informed consent requires that the This problem has been solved! Language limiting the subject's right to withdraw from the study should not be permitted in consent documents. Most institutions decide to apply the Common Rule to all research with human subjects, regardless of the funding source. 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. 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. The Formplus medical authorization form allows schools to collect formal consent from parents and guardians, in the case of a medical emergency involving their wards. Decisions about research ethics are always a matter of personal choice. C) Kilovoltage (kV) Thus, rather than an endpoint, the consent document should be the basis for a meaningful exchange between the investigator and the subject. 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) Another dentist A) Maintain a high standard of image quality. 16) Which word is least likely to be understood by the average patient? A) the statute of limitations. Wording such as: "will be your responsibility or that of your third-party payor" has been erroneously interpreted by some subjects to mean the insurance company is required to pay. 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. D) within 5 years from the date that the patient discovered an injury. The benefits of the research often lie in the importance of the knowledge to be gained. 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 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? 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. Which of the following statements is true? Clients have the freedom to choose whether to enter into or remain in . 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) 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) In an uncomfortable discussion, avoid eye contact with the patient. C) from the date that the patient discovers an injury. Each of them claims that she sees her own image but not the image of the other person. Which of the following statements is true? C) Fanning C) Patients may believe radiographs are not necessary or that they will add to treatment costs. C) Darkroom B) Consultation with other professionals The orientation should be done only once. The goal of psychological research is often to create statistical uncertainty and reduce methodological uncertainty. Consent documents should not contain unproven claims of effectiveness or certainty of benefit, either explicit or implicit, that may unduly influence potential subjects. 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. Note: Some of the material provided here was adapted from material available in CITI (Course in The Protection of Human Research Subjects). A) No image of a coin A) Solution levels must be replenished and changed on a regular basis. 16) Dental radiographs must be retained 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) To explain to you why they wish to leave so that you can conduct debriefing. B) Protected health-related information (PHI) Risks and Benefits Researchers tend to underestimate risks involved in activities with which they are familiar and to overestimate the benefits of things that are important to them. Researchers (including student researchers) are required to file a IRB prior to conducting research. monitor the data to ensure the safety of participants, Justice (Treat people fairly and design research so that its burdens and benefits are shared equitably) B) Reverse towne C) 1,500 The extent of the yearly review will vary depending on the research. Therefore, absolute protection of confidentiality by FDA should not be promised or implied. Routine Screening: Informed consent, fear, and substance abuse. A) ask the patient to pronounce his or her name for you. A) Waters B) The patient However, the IRB of record is the final authority on the content of the consent documents that is presented to the prospective study subjects. The investigator then photocopies the consent document for use. The fundamental ethical principles est. D) establishes standards for state certification/licensure of radiographic personnel. FDA does not require the investigator to personally conduct the consent interview. D) Follow strict protocols to protect oneself during exposures. risks to subjects should be reasonable in relation to both the potential benefits to the participants and the importance of the knowledge expected to result C) Submentovertex C) Tube-shift method, 7) Which of these extraoral radiographs is most often used to examine the sinuses? D) Test for darkroom light leaks. Informed Consent . 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. 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). 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. 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) risk management. A) Lateral cephalometric Declaration of Helsinki - adopted in 1964 . Certain types of studies qualify for exempt or expedited review. B) Axial D) The definitive method of localization is the least reliable. B) Allow the patient to choose who he or she wants to expose the radiographs. C) distilled water was not used. The Belmont Report says that the distinction between research and practice should be abandoned. A) "I know this is an uncomfortable procedure, so I'll be as quick as possible." B) the dryer was not operating correctly. D) Posteroanterior, 10) Which of these dental practitioners would most likely use a lateral cephalometric radiograph to assess growth and development? D) Black darkroom walls, 15) Which of the following indicates a passed coin test? B) Appropriate filter color Any substantive changes to the document made by an IRB must be submitted to FDA (by the sponsor) for review and approval. Risks in research participation are specific to time, situation, and culture. [TY14.1], 2. C) Aim for perfection with each radiograph. Five Requirements Based on Beneficence, use procedures that present the least risk to participants consistent with answering the scientific question A Certificate of Confidentiality protects sensitive information provided by research subjects from civil, criminal, or administrative subpoena. Which of the following is true about ethical research using animals? To complete the experimental session because you would not ask personal questions unless they were really important for science. The person(s) obtaining the subjects' consent, however, should be able to discuss available alternatives and answer questions that the subject may raise about them. A) It should be performed by a qualified expert only. The research participant must give voluntary . The Belmont Report outlined three basic ethical principles. 3) Which of the following statements regarding localization methods is false? B) the dryer was not operating correctly. a. Research is eligible for expedited review when it poses no more than minimal risk (minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greaterthan those ordinarily encountered in daily life) to the participants and when all the activities fall within the categories identified as eligible. C) Submentovertex They may be presented at a conference. Three Requirements Based on Respect for Persons, obtain and document informed consent 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. A) Lateral skull projection IRBs must either have sufficient expertise among their members or seek expertise through consultation if the members are not familiar with a methodology or population under consideration. A) three-surfaced composites. D) repeating requests several times to greater facilitate comprehension. 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. B) Medium 3) Which of the following statements regarding interpersonal skills is best? Informed consent is a highly technical document that adheres to strict regulations and might not be affected by unique local community requirements. 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. 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. A) ask the patient to pronounce his or her name for you. C) Evaluation of oral pathologic lesions B) The fastest film speed currently available should be used for all radiographs. 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. Df~ ,{|j4@@iWRO.wRF`7 :/bW$ Which one is the exception? Details of any deception. B) Orthodontist A witness is required to attest to the adequacy of the consent process and to the subject's voluntary consent. D) chairside manner. ", D) "Your radiographs are too dark but we corrected the problem. D) Ethics are laws and regulations pertaining to the behavior of the health care professional. D) Possible sources of light leaks include around the entry door and around pipes leading into the darkroom. 2136 0 obj <>stream C. An informed decision requires a clear understanding of the situation or subject. For some studies, however, the use of multiple documents may improve subject understanding by "staging" information in the consent process. What is the exact statement required to be included in informed consent documents? Three of these are frequently used by social and behavioral scientists: The regulations do allow some research with children to be exempt (although institutional policy may not). Which one is the exception? Our decisions impact how we use our time and money. They have been criticized for putting participants at risk of harm. When the consent interview is conducted in English, the consent document should be in English. Researchers are bound by a code of ethics that includes the following protections for subjects.