CITI Training Social and Behavioral Focus Practice Test

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• The primary purpose of a Certificate of Confidentiality is to:
• Which elements must be included in informed consent for a typical social/behavioral study?
• Which IRB review category is appropriate for minimal risk research that is not eligible for exemption?
• A researcher is studying the quality of life for prisoners who are HIV-positive using surveys followed by interview. The IRB must ensure that:
• A student plans to interview 15 principals about personal experiences with disruptive students, including disciplinary actions and thoughts on their appropriateness. The research data could impact the principals' careers, and identifiers will be collected. This study would be subject to which type of review?
• What is the purpose of de-identification with respect to PHI in research data?
• Under which study would it NOT be appropriate to provide missing elements of consent after the study?
• In a study of adults who experienced childhood abuse, with informed consent and confidentiality safeguards, what is the most likely additional risk to participants?
• HIPAA's protections for health information used for research purposes supplement those of which regulations?
• A medical record is an example of:
• The Belmont principle of beneficence requires that:
• When is it appropriate to use "publicly available data" or "public reports" in research, and what consent requirements apply?
• What is 'conflict of interest' in research, and how should it be managed?
• Which statement about IRB amendments is correct?
• Which scenario constitutes both a breach of confidentiality and a violation of subjects' privacy?
• In protecting data provenance and integrity, which practice is essential?
• How should researchers handle 'data sharing' or 'future use of identifiable data' in consent forms?
• Under HIPAA, a covered entity may disclose PHI without authorization for all of the following EXCEPT:
• What is 'insufficient consent,' and how can investigators ensure participants understand what they are consenting to?
• Which statement best describes IRB considerations regarding using prisoners as research participants?
• A researcher collects data by observing people in a public space without interacting with them. This data is typically categorized as which type?
• How should researchers handle data retention and destruction to protect participants' confidentiality?
• In a focus group on attitudes toward hygiene and disease prevention, a subject later experiences a heart attack at home and recovers. Should this be reported to the IRB under HHS regulations?
• How does non-therapeutic research apply to social/behavioral studies and risk?
• Which statement about confidentiality in focus groups dealing with sensitive topics is correct?
• Which scenario best illustrates that timing and context are key to assessing risk of harm in a research study?
• A graduate student plans an interview study with store owners about stock and sales, with no identifiers collected. This study would be subject to which type of IRB review?
• When is a breach response plan activated?
• Which statement best defines a human subject under federal regulations?
• Why can parental permission be problematic in research conducted in a clinical service setting?
• Online study risks include a unique risk: what is a potential harm?
• What is the role of sponsors and funders in the IRB review process for social/behavioral research?
• How do audio or video recording influence privacy considerations, and what protections should be in place?
• In addition to the general provisions of the Common Rule, which regulations govern research conducted in public schools?
• Additional safeguards that may be included in a social and behavioral study may include:
• What is re-contact with subjects, and why might it be considered in IRB review?
• 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 accurate?
• What considerations determine whether a social/behavioral study qualifies for expedited review?
• The internet can be used as a research tool. Which example best describes using the internet to conduct research?
• According to the Belmont Report, the requirement that benefits and burdens are equitably distributed expresses which principle?
• Under the Belmont Report, Respect for Persons requires researchers to treat individuals as autonomous agents and to provide additional protections for those with diminished autonomy. Which statement is true?
• What factors determine whether data are identifiable vs non-identifiable in reporting or analysis?
• What is data minimization?
• Under Belmont principles, researchers should minimize risks and maximize benefits. This statement best reflects which principle?
• What is the role of IRBs in ensuring subject protection in social/behavioral research?
• The HIPAA 'minimum necessary' standard applies to which of the following?
• According to the federal regulations, which study meets the definition of research with human subjects?
• When a research project includes the collection of biological samples, all planned future uses of the samples, identifiers, and the data obtained from the samples must be fully explained to the research subject. This statement is:
• What constitutes an "adverse event" in social/behavioral research, and how should researchers respond?
• What is the purpose of debriefing in deception-based research?
• How do confidentiality and privacy differ in research, and what strategies protect each in social/behavioral studies?
• Identifiable private information is best described as which of the following?
• When using retrospective data, what is a key consideration for IRB review regarding consent?
• Which scenario meets the federal definition of research with human subjects in an online setting?
• How does the CITI Social and Behavioral Focus course address digital privacy and the use of social media data in research?
• Which of the following is NOT a Belmont Report principle?
• What constitutes 'coercion' or 'undue influence' in participant recruitment, and how can researchers avoid it?
• What is risk/benefit analysis in IRB review, and give an example of a social/behavioral study with a favorable risk-benefit ratio?
• During the consent process, what do federal regulations require researchers to provide?
• 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 school, which of the following requirements must be met before an IRB could waive parental permission?
• In the U.S., the first federal regulations for human subjects research began in 1981 with the codification of the ________.
• A researcher observes preschoolers at a public playground without interacting with them and without recording identifying information. Which statement best describes the exemption status of this research?
• One IRB function includes reviewing recruitment materials and strategies to ensure ethical recruitment. This activity is best described as:
• What determines the age of majority in international research?
• Which statement best describes privacy in research ethics?
• According to federal regulations, which study meets the definition of research with human subjects?
• Which statement best defines exculpatory language in informed consent?
• Which are the three core ethical principles of the Belmont Report?
• Which disclosure is permissible without authorization under HIPAA?
• What is the most accurate statement about risks in social and behavioral sciences research?
• PPRA gives parents some level of control over their child's participation in what?
• How should quotes or case examples be handled to protect confidentiality in reporting?
• A survey-based study asks about highest education level, political affiliation, and views on social issues, with no identifiable information collected. This study would be subject to which type of IRB review?
• Which type of information may schools disclose without parental consent to a researcher at a local university?
• Which scenario would be most likely eligible for expedited IRB review?
• In the context of de-identification, which statement best describes the main purpose of not retaining identifying information?
• Under HIPAA, a 'disclosure accounting' is required:
• A researcher submits an IRB proposal to evaluate a new after-school online tutoring program for middle-school students in a local school district. She plans to conduct the assessment at the school her children attend because she is familiar with the district, and students may use their personal smartphones or computers to participate. This scenario might violate which Belmont principle?
• What is meant by 'minimal risk' in social/behavioral research, and which example best illustrates it?
• Which statement best describes the minimum necessary standard's application to PHI uses and disclosures?
• Which regulation provides extra protections for child participants in research?
• How should researchers address data provenance and data integrity in analysis and reporting?
• What is 'HIPAA,' and how does it relate to research in social and behavioral fields?
• A researcher collecting identifiable sensitive information about illicit drug use; one subject has an auto accident two weeks after participation. Is this an unanticipated problem that must be reported to the IRB?
• Which factor determines whether online activity constitutes research with human subjects?
• The Belmont principle of justice focuses on which of the following?
• PHI includes identifiable health information created or held by which entities?
• In a case-based research using data from children treated for behavior problems, what is a correct statement about parental permission?
• In research involving minors, which type of data requires the most protection due to its identifying nature?
• What are 'vulnerable populations' in social/behavioral research and why do they require additional protections?
• What is the impact of exemption status on institutional review requirements?
• What is an 'assurance of confidentiality' in a consent form?
• What is the difference between de-identified and anonymized data, and when is authorization or consent still required for using de-identified data?
• If a dataset contains identifying codes and is stored with limited access and encryption, which protection is primarily in use?
• A research informed consent form must describe ______.
• Which statement exemplifies the Belmont principle of beneficence in human subjects research?
• How should researchers handle mandatory reporting requirements in the context of sensitive disclosures (e.g., abuse) during a study?
• In a longitudinal study following children through high school and collecting information about illegal activities, which confidentiality measure protects against compelled disclosure?
• In the described illicit drug use research scenario, the unanticipated problem must be reported to the IRB in which timeframe?
• Under federal regulations, what is the Institutional Review Board primarily charged with?
• A study involves anonymous online surveys with no way to identify respondents. Which IRB outcome is most likely?
• Census data are considered what type of information for research purposes?
• Which set of principles is central to the Belmont Report?
• What is the principle of transparency in research ethics, and how is it maintained?
• What is debriefing, and when must it be provided in research that used deception?
• What is required when a study involves the use of identifiable private information or specimens from participants?
• What are 'confidential data sharing protections,' and what obligations do researchers have when sharing data with others?
• Which type of IRB review does not require IRB approval but requires a determination by a designated individual (such as an IRB member or experienced staff person)?
• In what circumstances is deception permissible in social/behavioral research, and what obligations follow if deception is used?
• Which example of research with prisoners would be allowable under the regulations?
• Under the Common Rule, which of the following is NOT considered a vulnerable population requiring additional protections?
• A graduate student wants to study print versus televised media effects using access to a prison population by a local work release facility. The IRB should:
• Which statement best describes the relationship between confidentiality and anonymity in research data?
• Which statement best describes the risk assessment framework for potential harms in social-behavioral research?
• Which practice best protects privacy in online surveys?
• How should 'incentives' for participation be used to avoid undue influence?
• Under the Common Rule, which of the following is NOT typically a vulnerable population requiring additional protections?
• Which statement best describes how researchers should plan for data sharing when identifiable information might be involved?
• When is de-identification sufficient to avoid using PHI in research under HIPAA?
• Which populations are protected by Subparts B, C, and D of 45 CFR 46?
• What term describes the ongoing evaluation of an already approved study?
• What is the general approach to digital privacy when collecting data from online platforms?
• Which statement best describes Subpart D focus?
• According to the federal regulations, which study meets the definition of research with human subjects?
• For a web-based survey of college students collecting information about sexual behavior and drug use, where direct identifiers are not collected but IP addresses may be present, risk of harm should be evaluated by which factors?
• Which item is commonly considered Directory Information under FERPA?
• Which statement best describes de-identification?
• In addition to pregnant women, fetuses, and neonates, which population has additional protections under HHS regulations?
• Which statement best reflects ongoing consent?
• In a study, the use of a consent form to convey study information exemplifies which Belmont principle?
• Who is typically responsible for addressing privacy concerns within an organization in HIPAA contexts?
• A foreign site study has been deemed exempt by the host institution's policy. According to federal regulations, is review required at the foreign site?
• If a research proposal involves oral histories and is not defined as research under federal regulations, what action would the IRB take?
• According to OHRP, an 'unanticipated problem' meets which criteria?
• What is a privacy impact assessment, and when is it typically conducted?
• Census data from the United States Census Bureau are an example of what type of information for research purposes?
• If you're unsure about the particulars of HIPAA research requirements at your organization, whom could you consult?
• Which of the following actions would most clearly contribute to protecting participants' privacy?
• Which federal regulation governs how researchers can obtain data about a student's disciplinary status from academic records?
• Which sentence in a consent form constitutes exculpatory language?
• What is the role of assent for minors, and when should it be sought?
• Which of the following is NOT typically part of a data security plan?
• Under what circumstance may a waiver of documentation of informed consent be appropriate?
• Data are made anonymous by destroying all identifiers connected to the data. What is the term that describes this process?
• Which practice best protects participant confidentiality when handling data retention?
• Which option correctly reflects the timing of continuing IRB oversight for non-exempt studies?
• Which statement best describes protected health information (PHI) under HIPAA?
• Under Subpart D Category 2, which scenario may be eligible for exemption?
• In the consent process, at what level should information be provided to potential subjects?
• For a study posing more than minimal risk that was initially approved by a convened IRB, continuing review must occur when?
• Which of the following is not among the three general risk categories in social/behavioral research?
• What is the role of data use agreements when sharing data with others?
• When a U.S. researcher conducts a study in a non-U.S. setting, besides subject consent, what other permission may need to be sought?
• What is a Certificate of Confidentiality, and when might researchers request one?
• Which method is a best practice for informing respondents how their answers will be protected in an online survey?
• Which statement best describes the Belmont principle of respect for persons?
• True or False: An adverse event that is clearly unrelated to the research and anticipated does not need to be reported as an unanticipated problem.
• In confidentiality planning for workplace research, which item must be addressed?
• Deception in research poses a risk to which Belmont principle?
• Which activity constitutes engagement in research?
• Subpart D protections apply to which type of research involving children?
• Consent to participate in research is an ongoing process. Which strategy helps ensure that participation in a survey about a sensitive personal topic remains voluntary?
• What should be included in consent forms regarding future use of data for research beyond the current study?
• Vulnerabilities related to employment may include which of the following? (Select the best option)
• How should a researcher respond if a participant expresses intent to harm themselves or others?
• A researcher is studying how deductive disclosure of identity may occur in a data set. The primary ethical violation is in which study?
• Which document outlines basic ethical principles for human subjects research?
• Which of the following is the most comprehensive approach to informed consent for participants with limited English proficiency?
• Subpart C concerns which of the following?
• A sociologist wants to study a culture that occurs in some women's prisons: 'state families,' in which individual prisoners take on certain roles within a group of like-minded prisoners. The lieutenant in charge of a dorm of long-term prisoners offers to gather volunteers to speak to the researcher and also offers to vouch for the integrity of the researcher. The use of this staff is:
• If a study collects identifiers and involves risk, it would be subject to which type of IRB review?
• Which practice best aligns with data minimization in study design?
• The purpose of FERPA is to provide parents certain rights over their children's educational records.
• Under federal regulations, which statement describes exemption eligibility?
• What is required for ongoing/continuing review of a previously approved social/behavioral study, and how often must it occur?
• Which statement about the relationship between an institution and its IRB is correct?
• A HIPAA authorization has which characteristic?
• Which scenario illustrates a study that would be eligible for expedited IRB review due to low risk?
• Identify one way faculty researchers can possibly avoid undue influence of student subjects.
• Which of the following is the least important activity when protecting human subjects in international research?
• What is the difference between 'exemption' and 'exemption categories,' and provide an example of exempt research?
• What should be included in the 'summary of risks and benefits' section of a consent form for a social/behavioral study?
• Which of the following is NOT typically considered a vulnerable population in social/behavioral research?
• Under expedited review, when may the process be used?
• For workplace confidentiality, a data management plan should specify which of the following?
• Which of the following is an element of a data security plan?
• What is a key purpose of reporting unanticipated problems to the IRB?
• When can a waiver of documentation of informed consent be granted?
• Risk of harm in social and behavioral sciences generally falls into which three categories?
• Which statement best describes FERPA's general rule about disclosing education records to researchers?
• 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?
• Which statement correctly describes continuing review in IRB oversight?
• Humphreys' Tearoom Trade study involved data collection under a deceptive pretense. This is a violation of which Belmont principle?
• What is the IRB's primary role in protecting human subjects?
• Which Belmont principle emphasizes respect for persons, including protection for those with diminished autonomy and the requirement for informed consent?
• What is the purpose of a disclosure accounting under HIPAA?
• How should institutional reporting obligations be communicated to participants and staff?
• How does the Common Rule define "identifiable private information," and why is it important for IRB review?
• Who determines the procedures for reporting potential unanticipated problems involving risk to subjects or others to the IRB?
• The Belmont Report example about burdens of serving as subjects falling on poor ward patients and benefits flowing to private patients illustrates a violation of which Belmont principle?
• Which study is most directly linked to the establishment of the National Research Act in 1974 and Belmont Report and federal regulations for human subjects protection?
• What types of IRB review exist and when is each appropriate for social/behavioral research?
• Why is cultural sensitivity and community engagement important in diverse populations for social/behavioral research?
• How do researchers protect privacy when collecting data via online surveys or digital platforms?
• Which practice promotes transparency in research?
• What is retrospective data use, and what additional considerations apply to IRB review?
• Which statement best describes the scope of assent in pediatric research?
• Where could student researchers and/or student subjects find additional resources regarding the IRB approval process?
• A researcher sits on a bench near a busy four-way stop to observe helmet use and whether riders stop before proceeding, to study risk-taking. This collection is an example of what kind of data collection?