CITI Training Social and Behavioral Focus Practice Test

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• The HIPAA 'minimum necessary' standard applies to which of the following?
• A research informed consent form must describe ______.
• Which example of research with prisoners would be allowable under the regulations?
• What is a Certificate of Confidentiality, and when might researchers request one?
• A researcher collects data by observing people in a public space without interacting with them. This data is typically categorized as which type?
• Which statement best describes the risk assessment framework for potential harms in social-behavioral research?
• What is the difference between 'exemption' and 'exemption categories,' and provide an example of exempt research?
• Subpart C concerns which of the following?
• What is 'insufficient consent,' and how can investigators ensure participants understand what they are consenting to?
• During the consent process, what do federal regulations require researchers to provide?
• Which statement best describes Subpart D focus?
• How should researchers handle data retention and destruction to protect participants' confidentiality?
• According to OHRP, an 'unanticipated problem' meets which criteria?
• Which of the following is NOT typically part of a data security plan?
• Under the Common Rule, which of the following is NOT typically a vulnerable population requiring additional protections?
• PPRA gives parents some level of control over their child's participation in what?
• What factors determine whether data are identifiable vs non-identifiable in reporting or analysis?
• According to the Belmont Report, the requirement that benefits and burdens are equitably distributed expresses which principle?
• Which statement about IRB amendments is correct?
• How do audio or video recording influence privacy considerations, and what protections should be in place?
• Which scenario constitutes both a breach of confidentiality and a violation of subjects' privacy?
• The Belmont principle of beneficence requires that:
• 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?
• When is de-identification sufficient to avoid using PHI in research under HIPAA?
• Which of the following is the most comprehensive approach to informed consent for participants with limited English proficiency?
• 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 among the three general risk categories in social/behavioral research?
• 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?
• HIPAA's protections for health information used for research purposes supplement those of which regulations?
• What is 'conflict of interest' in research, and how should it be managed?
• Which practice promotes transparency in research?
• How do researchers protect privacy when collecting data via online surveys or digital platforms?
• Which statement best describes IRB considerations regarding using prisoners as research participants?
• What is the role of sponsors and funders in the IRB review process for social/behavioral research?
• Under which study would it NOT be appropriate to provide missing elements of consent after the study?
• 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?
• Which scenario best illustrates that timing and context are key to assessing risk of harm in a research study?
• What is the principle of transparency in research ethics, and how is it maintained?
• Which set of principles is central to the Belmont Report?
• Vulnerabilities related to employment may include which of the following? (Select the best option)
• How should researchers handle mandatory reporting requirements in the context of sensitive disclosures (e.g., abuse) during a study?
• Which statement best describes FERPA's general rule about disclosing education records to researchers?
• What is meant by 'minimal risk' in social/behavioral research, and which example best illustrates it?
• 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?
• Which statement best describes privacy in research ethics?
• In the described illicit drug use research scenario, the unanticipated problem must be reported to the IRB in which timeframe?
• What is data minimization?
• What are 'vulnerable populations' in social/behavioral research and why do they require additional protections?
• What is the general approach to digital privacy when collecting data from online platforms?
• What should be included in consent forms regarding future use of data for research beyond the current study?
• In a study, the use of a consent form to convey study information exemplifies which Belmont principle?
• Identify one way faculty researchers can possibly avoid undue influence of student subjects.
• In the consent process, at what level should information be provided to potential subjects?
• 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?
• What is the purpose of debriefing in deception-based research?
• Which item is commonly considered Directory Information under FERPA?
• Under what circumstance may a waiver of documentation of informed consent be appropriate?
• Which statement best describes protected health information (PHI) under HIPAA?
• Which regulation provides extra protections for child participants in research?
• The Belmont principle of justice focuses on which of the following?
• Which of the following is NOT typically considered a vulnerable population in social/behavioral research?
• Which statement about confidentiality in focus groups dealing with sensitive topics is correct?
• What is required when a study involves the use of identifiable private information or specimens from participants?
• How do confidentiality and privacy differ in research, and what strategies protect each in social/behavioral studies?
• What is risk/benefit analysis in IRB review, and give an example of a social/behavioral study with a favorable risk-benefit ratio?
• Which practice best protects participant confidentiality when handling data retention?
• Which scenario meets the federal definition of research with human subjects in an online setting?
• Which statement about the relationship between an institution and its IRB is correct?
• A medical record is an example of:
• When using retrospective data, what is a key consideration for IRB review regarding consent?
• What determines the age of majority in international research?
• What is the difference between de-identified and anonymized data, and when is authorization or consent still required for using de-identified data?
• Which statement best reflects ongoing consent?
• What is an 'assurance of confidentiality' in a consent form?
• Which are the three core ethical principles of the Belmont Report?
• Which statement best defines a human subject under federal regulations?
• A researcher is studying the quality of life for prisoners who are HIV-positive using surveys followed by interview. The IRB must ensure that:
• When is it appropriate to use "publicly available data" or "public reports" in research, and what consent requirements apply?
• One IRB function includes reviewing recruitment materials and strategies to ensure ethical recruitment. This activity is best described as:
• What is a privacy impact assessment, and when is it typically conducted?
• 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?
• What is the purpose of a disclosure accounting under HIPAA?
• Under the Common Rule, which of the following is NOT considered a vulnerable population requiring additional protections?
• If a study collects identifiers and involves risk, it would be subject to which type of IRB review?
• Why is cultural sensitivity and community engagement important in diverse populations for social/behavioral research?
• Subpart D protections apply to which type of research involving children?
• Under HIPAA, a 'disclosure accounting' is required:
• Which populations are protected by Subparts B, C, and D of 45 CFR 46?
• Which statement best describes the relationship between confidentiality and anonymity in research data?
• The primary purpose of a Certificate of Confidentiality is to:
• Which statement correctly describes continuing review in IRB oversight?
• Deception in research poses a risk to which Belmont principle?
• In a longitudinal study following children through high school and collecting information about illegal activities, which confidentiality measure protects against compelled disclosure?
• According to federal regulations, which study meets the definition of research with human subjects?
• What are 'confidential data sharing protections,' and what obligations do researchers have when sharing data with others?
• Which disclosure is permissible without authorization under HIPAA?
• If a dataset contains identifying codes and is stored with limited access and encryption, which protection is primarily in use?
• Data are made anonymous by destroying all identifiers connected to the data. What is the term that describes this process?
• What is the impact of exemption status on institutional review requirements?
• In research involving minors, which type of data requires the most protection due to its identifying nature?
• What term describes the ongoing evaluation of an already approved study?
• In confidentiality planning for workplace research, which item must be addressed?
• 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?
• Census data are considered what type of information for research purposes?
• Which elements must be included in informed consent for a typical social/behavioral study?
• 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?
• 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 should institutional reporting obligations be communicated to participants and staff?
• Under federal regulations, what is the Institutional Review Board primarily charged with?
• What is a key purpose of reporting unanticipated problems to the IRB?
• In what circumstances is deception permissible in social/behavioral research, and what obligations follow if deception is used?
• How should researchers address data provenance and data integrity in analysis and reporting?
• 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?
• 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?
• A study involves anonymous online surveys with no way to identify respondents. Which IRB outcome is most likely?
• In addition to the general provisions of the Common Rule, which regulations govern research conducted in public schools?
• Which sentence in a consent form constitutes exculpatory language?
• How should quotes or case examples be handled to protect confidentiality in reporting?
• How does the Common Rule define "identifiable private information," and why is it important for IRB review?
• How should 'incentives' for participation be used to avoid undue influence?
• 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?
• What constitutes 'coercion' or 'undue influence' in participant recruitment, and how can researchers avoid it?
• Which statement exemplifies the Belmont principle of beneficence in human subjects research?
• How should a researcher respond if a participant expresses intent to harm themselves or others?
• What is the role of assent for minors, and when should it be sought?
• In the context of de-identification, which statement best describes the main purpose of not retaining identifying information?
• What is retrospective data use, and what additional considerations apply to IRB review?
• Census data from the United States Census Bureau are an example of what type of information for research purposes?
• Which statement best describes how researchers should plan for data sharing when identifiable information might be involved?
• 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?
• If a research proposal involves oral histories and is not defined as research under federal regulations, what action would the IRB take?
• Identifiable private information is best described as which of the following?
• What is the purpose of de-identification with respect to PHI in research data?
• Which document outlines basic ethical principles for human subjects research?
• 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 scope of assent in pediatric research?
• What is debriefing, and when must it be provided in research that used deception?
• What should be included in the 'summary of risks and benefits' section of a consent form for a social/behavioral study?
• Which option correctly reflects the timing of continuing IRB oversight for non-exempt studies?
• 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?
• A researcher is studying how deductive disclosure of identity may occur in a data set. The primary ethical violation is in which study?
• 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)?
• When can a waiver of documentation of informed consent be granted?
• Which type of information may schools disclose without parental consent to a researcher at a local university?
• What is the most accurate statement about risks in social and behavioral sciences research?
• What is re-contact with subjects, and why might it be considered in IRB review?
• PHI includes identifiable health information created or held by which entities?
• In addition to pregnant women, fetuses, and neonates, which population has additional protections under HHS regulations?
• Additional safeguards that may be included in a social and behavioral study may include:
• In a case-based research using data from children treated for behavior problems, what is a correct statement about parental permission?
• Who determines the procedures for reporting potential unanticipated problems involving risk to subjects or others to the IRB?
• What is the IRB's primary role in protecting human subjects?
• Under federal regulations, which statement describes exemption eligibility?
• Under expedited review, when may the process be used?
• 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?
• Which Belmont principle emphasizes respect for persons, including protection for those with diminished autonomy and the requirement for informed consent?
• Which practice best protects privacy in online surveys?
• 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:
• In protecting data provenance and integrity, which practice is essential?
• Risk of harm in social and behavioral sciences generally falls into which three categories?
• In the U.S., the first federal regulations for human subjects research began in 1981 with the codification of the ________.
• According to the federal regulations, which study meets the definition of research with human subjects?
• Why can parental permission be problematic in research conducted in a clinical service setting?
• Which of the following is NOT a Belmont Report principle?
• A HIPAA authorization has which characteristic?
• When is a breach response plan activated?
• Who is typically responsible for addressing privacy concerns within an organization in HIPAA contexts?
• Humphreys' Tearoom Trade study involved data collection under a deceptive pretense. This is a violation of which Belmont principle?
• Which of the following is the least important activity when protecting human subjects in international research?
• Where could student researchers and/or student subjects find additional resources regarding the IRB approval process?
• What constitutes an "adverse event" in social/behavioral research, and how should researchers respond?
• What is the role of IRBs in ensuring subject protection in social/behavioral research?
• If you're unsure about the particulars of HIPAA research requirements at your organization, whom could you consult?
• How does non-therapeutic research apply to social/behavioral studies and risk?
• What is required for ongoing/continuing review of a previously approved social/behavioral study, and how often must it occur?
• Which statement best describes the minimum necessary standard's application to PHI uses and disclosures?
• Which federal regulation governs how researchers can obtain data about a student's disciplinary status from academic records?
• Under Subpart D Category 2, which scenario may be eligible for exemption?
• 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?
• 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 statement best defines exculpatory language in informed consent?
• Which of the following actions would most clearly contribute to protecting participants' privacy?
• Which activity constitutes engagement in research?
• Which of the following is an element of a data security plan?
• 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?
• For workplace confidentiality, a data management plan should specify which of the following?
• The purpose of FERPA is to provide parents certain rights over their children's educational records.
• What is the role of data use agreements when sharing data with others?
• Which scenario would be most likely eligible for expedited IRB review?
• 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?
• Which practice best aligns with data minimization in study design?
• Which statement best describes de-identification?
• In a study of adults who experienced childhood abuse, with informed consent and confidentiality safeguards, what is the most likely additional risk to participants?
• Which IRB review category is appropriate for minimal risk research that is not eligible for exemption?
• Under Belmont principles, researchers should minimize risks and maximize benefits. This statement best reflects which principle?
• 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.
• What types of IRB review exist and when is each appropriate for social/behavioral research?
• For a study posing more than minimal risk that was initially approved by a convened IRB, continuing review must occur when?
• According to the federal regulations, which study meets the definition of research with human subjects?
• The internet can be used as a research tool. Which example best describes using the internet to conduct research?
• Under HIPAA, a covered entity may disclose PHI without authorization for all of the following EXCEPT:
• What is 'HIPAA,' and how does it relate to research in social and behavioral fields?
• Online study risks include a unique risk: what is a potential harm?
• Which scenario illustrates a study that would be eligible for expedited IRB review due to low risk?
• Which factor determines whether online activity constitutes 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:
• How should researchers handle 'data sharing' or 'future use of identifiable data' in consent forms?