citi study set
The specific U.S. Department of Health and Human Services (HHS) regulations that apply to research with children are known as Subpart D: Additional Protections for Children Involved as Subjects in Research
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According to the federal regulations, research is eligible for exemption, if:
the research falls into one of eight categories of research activity described in the regulations.
The researcher's failure to protect research subjects from deductive disclosure of identity (that is, the re-identification of subjects by other researchers) is the primary ethical violation in which of the following studies?
"Tastes, Ties, and Time (T3)" study
According to the federal regulations, which of the following studies meets the definition of research with human subjects?
A developmental psychologist videotapes interactions between groups of toddlers and their caregivers to determine which intervention methods most effectively manage aggression.
Which of the following constitutes both a breach of confidentiality (the research data have been disclosed, counter to the agreement between researcher and subjects) and a violation of subjects' privacy (the right of the individuals to be protected against intrusion into their personal lives or affairs)?
A faculty member makes identifiable data about sexual behavior available to graduate students, although the subjects were assured that the data would be de-identified.
Which is an example of a situation where deferential vulnerability might be a factor?
A physician recruiting patients to be subjects
A criterion for waiving informed consent is that, when appropriate, subjects are provided additional pertinent information after the study. In which of the following studies would it NOT be appropriate to provide subjects with information about missing elements of consent:
A study in which subjects were assigned to study activities based on an undesirable or unflattering physical characteristic as assessed by members of the research team.
According to the federal regulations, which of the following studies meets the definition of research with human subjects?
A study of twenty 4th grade classrooms in which researchers ask the schools to systematically vary the time of day reading is taught, and collect weekly assessments of reading comprehension for each child over a three-month period.
An example of an institutional COI is:
An industry sponsor pays for the construction of a new research laboratory at the organization
The FDA regulations governing disclosure of individual COIs require:
Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies
A researcher wants to do a web-based survey of college students to collect information about their sexual behavior and drug use. Direct identifiers will not be collected; however, IP addresses may be present in the data set. Risk of harm should be evaluated by:
Both the magnitude (or severity) and the probability (or likelihood) of harm.
The NBAC looks at characteristics individuals might have that would prevent them from being able to provide voluntary informed consent. The traits may be thought of as falling into six broad areas: cognitive or communicative, institutional, deferential, medical, economic, and social. Prospective research subjects who are not able to comprehend information, deliberate, and make decisions about participation in a proposed research study have a:
Cognitive or communicative vulnerability
Which of the following examples of using the internet to conduct research meets the federal definition of research with human subjects?
Conducting an on-line focus group with cancer survivors to determine familial support systems. The researcher also invites subjects' significant others to be a part of the focus group
Consent to participate in research is an ongoing process. Which of the following strategies would help ensure that participation in a survey about a sensitive personal topic remains voluntary throughout a study?
Designing the survey so that subjects are not forced to answer one question before going to the next.
Data are made anonymous by
Destroying all identifiers connected to the data
The procedures for reporting potential unanticipated problems involving risk to subjects or others to the IRB are:
Determined by the institution in its written policies and procedures
During an Institutional Review Board (IRB) meeting, any IRB member who may have a potential COI with a study under review should:
Disclose their potential COI and may answer questions, but recuse themselves from voting
A subject participates in a drug study because treatment is available at no or reduced cost, and he could not otherwise afford it
Economic vulnerability
Which of the following is an example of how the principle of beneficence is applied to a study involving human subjects?
Ensuring that risks are reasonable in relationship to anticipated benefits
Which example of research with prisoners would be allowable under the regulations?
Examining age at first arrest as a predictor of adult criminal history.
In addition to the general provisions of the Common Rule (the federal regulations for protecting research subjects), the following regulations also govern research in the public schools:
FERPA, PPRA, and Subpart D of the federal regulations
Which of the following statements most accurately describes the requirement for the documentation of minors' assent to participate in research?
Federal regulations do not require the documentation of minors' assent
What are some considerations for a U.S. researcher conducting a study in a non-U.S. setting when obtaining informed consent from subjects?
In addition to the consent of the research subjects, are there other individuals or groups whose permission must be sought?
Researchers must report potential unanticipated problems that involve risks to others directly to the:
Institutional Review Board (IRB)
Risk of harm in social and behavioral sciences generally fall in three categories, which are:
Invasion of privacy, breach of confidentiality, and study procedures
A researcher's study uses an identifiable dataset of prisoner demographic characteristics. This dataset includes criminal history data that predates incarceration and includes data on disciplinary behavior while in prison. There is no interaction with prisoners. The researcher claims, and the IRB chair agrees, that the study is exempt from IRB review. This decision:
Is wrong because 46.104 states that research conducted in prisons is not exempt if the subject population is only prisoners.
The age of majority in international research is determined by the
Laws, customs, and norms in the area in which the research will be conducted.
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.
According to federal regulations, the expedited review process may be used when the study procedures pose:
No more than minimal risk and the research activities fall within regulatory categories identified as eligible.
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?
No, they are not engaged because they are only informing the subjects and not consenting or performing any research procedures, or receiving or sharing any private, identifiable information
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?
No, this does not need to be reported because it is unrelated to participation in the study
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 accident two weeks after participating in the research study. Is this an example of an unanticipated problem that requires reporting to the IRB?
No, this does not need to be reported because it was assessed by the researcher as unrelated to the research study.
A researcher is studying women recently admitted to a state prison. All potential subjects must have children under the age of five. Research subjects will be given a basket of toys to use at their children's first visit that the children can then take home. In assessing this proposal, the IRB needs to determine that the toys are:
Not an excessive incentive.
Which of the following activities constitutes engagement in research?
Obtaining informed consent and conducting research interviews.
Which of the following statements about the relationship between an institution and the institution's IRB(s) is correct?
Officials of the institution may overrule an IRB approval.
Parental notification, in lieu of active parental permission, is allowed when:
Parental notification, in lieu of active parental permission, is allowed when:
PPRA gives parents some level of control over their child's:
Participation in third-party survey research or exposure to instructional materials developed by researchers
According to federal regulations, "children" are defined as:
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.
According to the authors, there are four common abuses that historically are described as giving rise to vulnerability. Which response below contains the correct four?
Physical control, coercion, undue influence, and manipulation
What procedures must be described in an agreement called an "assurance of compliance" with a U.S. federal agency?
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.
The primary purpose of a Certificate of Confidentiality is to:
Protect identifiable research information from compelled disclosure
The purpose of the Family Educational Rights and Privacy Act (FERPA) is to:
Provide parents certain rights over their children's educational records.
As part of the consent process, the federal regulations require researchers to:
Provide potential subjects with information at the appropriate reading comprehension level.
The COI management plan aims to:
Provide procedures or extras steps to be taken to minimize the risk of bias when a COI is disclosed
A researcher is interested in assessing risk-taking by individuals. The researcher is sitting on a bench near a busy four-way stop intersection. She plans on recording the number of bike riders wearing a safety helmet and whether they stop at the intersection before proceeding in order to correlate use of safety apparel with risk-taking. This collection of information is an example of:
Public behavior
Additional safeguards that may be included in a social and behavioral study may include:
Remove all direct identifiers from the data as soon as possible.
The PHS regulations about financial conflict of interests require which party to disclose significant financial conflicts of interest?
Researcher
Researchers endeavoring to conduct an on-line study should consider that there are some potential risks of harm to subjects unique to internet-based research. One of these risks is:
Researchers endeavoring to conduct an on-line study should consider that there are some potential risks of harm to subjects unique to internet-based research. One of these risks is:
Which of the following statements about prison research is true?
Researchers may study the effects of privilege upgrades awarded by the prison.
In a longitudinal study that will follow children from kindergarten through high school and will collect information about illegal activities, which of the following confidentiality procedures would protect against compelled disclosure of individually identifiable information?
Securing a Certificate of Confidentiality
In considering NBAC's analytic approach, an otherwise competent person who is acutely ill might be considered at especially high risk of harm for:
Situational cognitive vulnerability
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?
Taking part in the research is voluntary, but if you choose to take part, you waive the right to legal redress for any research-related injuries.
Which federal regulation or law governs how researchers can obtain data about subjects' disciplinary status in school from academic records?
The Family Educational Rights and Privacy Act
Which of the following methods could be considered a "best practice" in terms of informing respondents how their answers to an on-line survey about personal information will be protected?
The investigator uses the informed consent process to explain how respondent data will be transmitted from the website to his encrypted database without ever recording respondents' IP addresses, but explains that on the internet confidentiality cannot be absolutely guaranteed.
A waiver of the requirement for documentation of informed consent may be granted when:
The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality.
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?
The parents of the children might feel pressure to give permission to the therapist to use their children's data so that she will continue to provide services to their children.
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?
The research must pose no more than minimal risk.
When a focus group deals with a potentially sensitive topic, which of the following statements about providing confidentiality to focus group participants is correct?
The researcher cannot control what participants repeat about others outside the group.
According to OHRP, a problem is an "unanticipated problem" when it meets which of the following criteria:
Unexpected, unrelated or possibly related to the research suggest the research puts subjects others at greater
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?
Unless the nature of the questions would raise the level of risk to more than minimal for adolescents, the research would still qualify for expedited review.
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. There is previous evidence that younger prisoners will use older inmates who play the roles of grandparents as a resource before they will turn to staff for help and advice. 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:
Wrong and is prohibited; subject selection needs to be free from intervention by prison authorities or prisoners.
According to the Belmont Report, the requirement that the benefits and burdens of the research are equitably distributed, expresses the principle of:
justice
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 principle?
justice
A census is a regularly-occurring and official count of a particular population. Census data available at the United States Census Bureau website are an example of:
public information
Humphreys' collecting data for the Tearoom Trade study under the pretense that he was a lookout is an example of a violation of the principle of:
respect for persons
A professor at Big State University is writing a biography about Bill Gates and conducting oral histories with all of Bill Gates' friends, family members, and business acquaintances. The researcher submits the research proposal to the institution's IRB. What action can he expect by the IRB?
the IRB will not review this study because it is not research as defined by the federal regulations.
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?
There was neither a violation of privacy nor a breach of confidentiality.
The internet can be used as a research tool or as the object of a study. Which of the following examples best describes an investigator using the internet as a research tool?
An investigator uses his Facebook wall to post a URL link to a survey he is hosting on SurveyMonkey.
A researcher wishes to study generational differences in coping mechanisms among adults who experienced abuse as children. Adequate measures will be instituted to obtain informed consent and ensure that there is no breach of confidentiality. The most likely additional risk is that some subjects may:
Experience emotional or psychological distress.
In addition to pregnant women, fetuses, and neonates, another subpart of the HHS regulations provides additional protections for which of the following vulnerable populations?
prisoners
