CITI Human Subjects Research, IRB Exams Prep 2024-2025 Guide, Exams of Research Methodology

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CITI Human Subjects Research, IRB Exams Prep 2024-2025 Guide

CITI Human Subjects Research, IRB Exams Prep 2024-2025 Guide Which of the following scudies would need IRB approval? - SORRECGIINSWERE Studies collecting identifiable information about living individuals. Identify one way faculey researchers can possibly avoid undue influence of scudent subjects? - GORRECI ANSWER Avoid recruiting their own students in the research Under the U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) regulations, what is the Institutional Review Board (IRB) charged with? Select all that apply. - CORRECT ANSWER -- Protecting the rights and welfare of human subjects.- Assuring that researchers follow all applicable institutional policies and federal regulations related to research with human subjects.- Reviewing subject recruitment materials and strategies. Where could student researchers and/or student subjects find additional resources regarding the IRB approval process? Select all chat apply. - GORRIEGIIAINGWVERI- Faculty Advisor/Research Mentor - IRB Office In the U.S., the first federal regulations for human subjects research began in 1981 with the codification of the a GORRECTANSWER-Common Rule Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects? - GORRECTANSWERL Determining thac the study has a maximization of benefits and a minimization of risks. Which of the following are the three principles discussed in the Belmont Report? - SORRECDANSWERI- Respect for Persons, Beneficence, Justice The Belmont Report's principle of respect for persons incorporates at least two ethical convictions: first, that individuals should be treated 28 autonomous agents, and second, that: - SORREGINANSIERI Persons wich diminished autonomy are entitled to protection. Your informed consent form must describe CORRECT ANSWER -All foreseeable risks and discomforts. A student plans on interviewing 15 principals in neighboring high schools. The student plans to collect data about the personal experiences the principals have had with disruptive students, including the types of disciplinary actions that were taken (including decisions they may have personally made) and their feelings or thoughts regarding whether those actions were appropriate. The research data collected could have an impact on the principals’ careers. The student will collect identifiers. This study would be subject to which type of review? CORRECT ANSWER -Corvened Review GORRECTMNSWER Risks to subjects are reasonable The Belmont principle of beneficence requires that in relation to anticipated benefits, An example cited in the Belmont Report (The National Commission 1979) stated that "During the 19th and early 20th centuries the burdens of serving as research subjects fell largely upon poor ward patients, while the benefits of improved medical care flowed primarily to private patients.” This is an example of a violation of which Belmont principl According co the Belmont Report, the requirement that the benefits and burdens of the research are equitably distributed, expresses the principle of: GORRECTANSWER Justice A study was submitted to the TRB designed to evaluate the effect of background noise on an individual's ability co concentrate and answer questions. The IRB approved the study and consent form. The consent form includes all the required information. The use of a consent form is an example of the Belmont principle of - SORREGIANSWMBR Rp: or persons In addition co pregnant women, fetuses, and neonates, another subpart of the HHS regulations provides additional protections for which of the following vulnerable populations? - GORRECIANS WER Prisoners According to federal regulations, the expedited review process may be used when the study procedures pose: - GORREGWANSWR.No more than minimal risk and the research activities fall within regulatory categories identified as eligible. Continuing review of an approved and ongoing study posing more than minimal risk that was initially approved by a convened IRB: Must occur within 12 months of the approval date. What statement about risks in social and behavioral sciences research is most accurate: CORRECT AINSWERI-Risks are specific to time, situation, and culture. A researcher wishes to study generational differences in coping mechanisms among adults who experienced abuse as children. Adequate measures will be insticuted to obtain informed consent and ensure that there is no breach of confidentiality. The most likely additional risk is that some subjects may: CORRECT ANSWER - Experience emotional or psychological distress. If disclosure of a subject's involvement in a specific research study can be potentially harmful to the subject, and the consent form is the only record linking the subject to the research, which of the following would be GORRECTANGWER. Obcain a waiver of documentation of informed consent. most helpful: (CORREGIANSER, Proce denise The primary purpose of a Certificate of Confidentiality is to: research information from compelled disclosure Identify the example of when situation and time are key to assessing risk of harm in a research stud: GORRECTANSWER Asking women if they have had an abortion A therapist at a free university clinic treats elementary school children with behavior problems who are referred by a social service agency. She is also a doctoral candidate who proposes using data she has and will collect about the children for a case-based research project. Which of the following statements about parental permission is correct? - GORREGMANS WER! The parents of the children might feel pressure to give permission to the therapist co use their children’s data so that she will continue to provide services to their children. A general requirement for informed consent is that no informed consent may include any exculpatory language. Exculpatory language is that which waives or appears to waive any of the subject's legal rights or releases or appears to release those conducting the research from liability for negligence. Which of the following statements in a consent form is an example of exculpatory language? - GORRECTANSWERI- Taking part in the research is voluntary, but if you choose to take part, you waive the right co legal redress for any research-related injuries. A criterion for waiving informed consent is that, when appropriate, subjects are provided additional pertinent information after the study. Tn which of the following studies would it NOT be appropriate to provide CORRECT ANSWER. A study in which subjects were assigned to study activities based on an undesirable or unflattering physical characteristic as subjects with information about missing elements of consent: assessed by members of the research team. AINSWERI-The only record linking the subject and the research is the consent document and the principal Awaiver of the requirement for documentation of informed consent may be granted when: tisk is a breach of confidentiality. Provide potential subjects with information at the appropriate reading comprehension level. As part of the consent process, the federal regulations require researchers to: A researcher leaves a research file in her car while she attends a concert and her car is stolen. The file contains charts of aggregated numerical data from a research study with human subjects, but no other documents. The consent form said that no identifying information would be retained, and the researcher adhered to that component. Which of the following statements best characterizes what occurred? - GORRECIANSWERL- There was neither a violation of privacy nor a breach of confidentiality. A researcher is examining the quality of life for prisonets who are HIV-positive using surveys followed by GORRECTANGWER. Confidentiality of the prisoners’ health status interview. The IRB must ensure that is maintained. You learn that one of the subjects from your study will be admitted to prison next week. You assert that it is in the best interest of the subject to remain in the study while incarcerated. However, the study was not approved by the IRB in accordance with the requirements for research involving prisoners under Subpart C. What is the best course of action? - GORRECGANSWERL Notify the IRB promptly and allow the subject vo remain in the study while the IRB makes the determinations required by the regulations. According to Subpart D, research with children may be eligible for exemption under Category 2 when: - CORRECT ANSWER -The research involves the use of educational tests According to federal regulations, “children” are defined as: - GORRECTENGWER Persons who have not yet attained the legal age of consent under the applicable laws in the jurisdiction in which the research will be conducted. A researcher asks an IRB to waive the requirement for parental permission for a study conducted in schools because the nature of the research requires participation of all the children present in classrooms on the day the research will take place. Assuming that the basic research design could be approved by the IRB and the hool, which of the following requirements must be met before an IRB could waive parental permissio CORRECT ANSWER - The research must pose no more than minimal risk. The provisions of Subpart D, of the HHS regulations, Additional Protections for Children Involved as CORRECT ANSWER. All research funded by HHS Subjects in Research apply to A study that involves interviews of adults is eligible for expedited review. The researcher wants to add an adolescent population (aged 12 to 17) to the study and has designed a parental permission and assent process. No additional changes are planned. Which of the following statements about review of the revised protocol is GORRECTANGWER. Unless the nature of the questions would raise the level of risk co more than minimal for adolescents, the research would still qualify for expedited review. accurate? The purpose of the Family Educational Rights and Privacy Act (FERPA) is to: Provide parents certain rights over their children's educational records. Which federal regulation or law governs how researchers can obtain data about subjects’ disciplinary status in school from academic records? - SGRRIEGTANSNIERL- The Family Uducational Rights and Privacy Ace. Which of the following types of information may schools disclose without consent from the parent or student to a researcher at a local university? - GORRECTENS WER Directory information. If the research is subject to Subpart D, which of the following research activities with children would qualify for an exemption under Category 2 (research that includes educational tests, surveys, interviews, observation)? - GORRECTMINGWER Research about aptitude testing CORRECHANSIER. As 125 Parental notification, in lieu of active parental permission, is allowed when has approved a waiver of the requirement for parental permission. A professor at Big State University proposes to study attitudes about obesity in Chile by giving subjects in Chile surveys to complete. Which is a question that the Big State University IRB should ask the researcher in order to determine if this study should be reviewed by a Local Chilean IRB or ethics committee, as well as the Big State University IRB? - CORRECT ANSWER -W/ill the researchers have collaborators at the research site abroad? What procedures must be described in an agreement called an “assurance of compliance" with a U.S. federal GORRECTINGWER Procedures in place that ensure that subjects will be protected in a manner commensurate with the Common Rule, including review by an independent committee comparable to an IRB. agency? A researcher proposes a study and wants to recruit subjects from health care clinics in Jamaica. The survey will be conducted by the U.S. researchers at the clinic, The nurses at the clinic will inform prospective subjects about the availability of the research, but will not consent the subjects nor perform any research procedures (even screening procedures), Are the nurses engaged in the research according to federal regulations? - the website to his encrypted database without ever recording respondents’ IP addresses, but explains that on the internet confidentiality cannot be absolutely guaranteed. HIPAA's protections for health information used for research purposes... - CORRECT ANSWER - Supplement those of the Common Rule and FDA. The HIPAA “minimum necessary" standard applies... - @ORRECHANSWER! To all human subjects research that uses PHI without an authorization from the data subject A covered entity may use or disclose PHI without an authorization, or documentation of a waiver or an alteration of authorization, for all of the following EXCEPT: - @@RIREGIANSWERI Daca thac does not cross state lines when disclosed by the covered entity. Under HIPAA, a “disclosure accounting” is required: - CORRECT ANSWER -For all human subjects research that uses PHI without an authorization from the data subject, except for limited data sets. A HIPAA authorization has which of the following characteristics: CORRECT ANSWER Use "psin language” that che data subject can understand, similar co the requirement for an informed consent document. The peer review process can create conflicts of interest because the choice of who reviews a potentially publishable project may show: - GORREGHENSWER!There may be bias by the peer reviewer as to the area of research There may be bias by the peer reviewer as to the area of research - S@RREGHANSWER-It may be difficult for che researcher to appear neutral, as the researcher may have an interest in the research's success The FDA regulations governing disclosure of individual COIs require: - GORRECTANSWER Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies During an Institutional Review Board (IRB) meeting, any IRB member who may have a potential COI with a scudy under review should: - SORRIEGTIANSNTERI-( but recuse themselves from voting lose their potential COT and. may answer questions, The PHS regulations about financial conflict of interests require which party to disclose significant financial conflicts of interest? - GORRECTANSWER Researcher A researcher conducting behavioral research collects individually identifiable sensitive information about illicit drug use and other illegal behaviors by surveying college students. The data are stored on a laptop computer without encryption, and the laptop computer is stolen from the researcher's car on the way home from work. This is an unanticipated problem that must be reported because the incident was (a) unexpected (in other words, the researchers did not anticipate the theft); (b) related to participation in the research; and (c) placed the subjects ata greater risk of psychological and social harm from the breach in confidentiality of the study data than was previously known or recognized. According to OHRP, this unanticipated problem must be reported to the IRB in which timeframe? - GORRECTANS WEP rompily A researcher conducting behavioral research collects individually identifiable sensitive information about illicit drug use and other illegal behaviors by surveying college students. One of the subjects is in an automobile accidenc two weeks after participating in the research study. Is this an example of an unanticipated problem that requires reporting to the IRB? - CORRECT ANSWER -No, this does not need to be reported because it was assessed by the researcher as unrelated to the research study. The procedures for reporting potential unanticipated problems involving risk to subjects or others to the IRB are: - GORREGHANSWER)-Decermined by the insticution in its written policies and procedures A researcher conducts a focus group to learn about attitudes towards hygiene and disease prevention. Two weeks after the focus group, the researcher learns one of the subjects had a heart attack at home and was hospitalized, but made a full recovery. Based on HHS regulations, should the researcher report this event to the IRB? - CORRECT ANSWER -No, this does nor need to be reported because it is unrelated co participation in the study.