CITI social behavior research course quiz
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?
A researcher's spouse holds equity in a publicly traded pharmaceutical company that is also the sponsor of the researcher's study.
An example of an individual financial COI is:
Provide potential subjects with information at the appropriate reading comprehension level.
As part of the consent process, the federal regulations require researchers to:
Supplement those of the Common Rule and FDA.
HIPAA's protections for health information used for research purposes...
respect for persons
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:
Directory information.
Which of the following types of information may schools disclose without consent from the parent or student to a researcher at a local university?
The researcher will ask for a waiver to document informed consent and instead will have a live button that reads, "If you agree to be in this study click below to begin."
Which scenario best describes a researcher making thoughtful considerations in the design of their informed consent process on an online study?
Uses "plain language" that the data subject can understand, similar to the requirement for an informed consent document.
A HIPAA authorization has which of the following characteristics:
Public Information
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:
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.
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:
No later than the time of proposal submission
A researcher calls you stating that he plans to submit a proposal to the NIH for a human subjects research study. He wants to know at what point he and his study team must submit COI disclosures to comply with the PHS regulation
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 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 only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality.
A waiver of the requirement for documentation of informed consent may be granted when:
The research involves the use of educational tests
According to Subpart D, research with children may be eligible for exemption under Category 2 when:
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 federal regulations, "children" are defined as:
No more than minimal risk and the research activities fall within regulatory categories identified as eligible.
According to federal regulations, the expedited review process may be used when the study procedures pose:
Designing the survey so that subjects are not forced to answer one question before going to the next.
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?
Must occur within 12 months of the approval date.
Continuing review of an approved and ongoing study posing more than minimal risk that was initially approved by a convened IRB:
PPRA applies.
If research in a private school is directly funded by the Department of Education, then:
Securing a Certificate of Confidentiality
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?
Prisoners
In addition to pregnant women, fetuses, and neonates, another subpart of the HHS regulations provides additional protections for which of the following vulnerable populations?
Individuals may post private identifiable information about themselves on-line without intending it to be public and available to researchers.
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:
Participation in third-party survey research or exposure to instructional materials developed by researchers
PPRA gives parents some level of control over their child's:
All of the above
Researcher access to confidential records adds to the vulnerability of workers who participate in workplace studies. Inappropriate release of identifiable private information could adversely affect a worker's retention of a job, insurance, or other employment related benefits. To avoid or minimize these risks, the study design must include adequate safeguards to protect the confidentiality of the information collected. A plan for the proper management of study data and records should clearly define:
Re-identification methods are unique to internet-based research.
Researchers designing online studies should consider the following with respect to participant protections.
Invasion of privacy, breach of confidentiality, and study procedures
Risk of harm in social and behavioral sciences generally fall in three categories, which are:
Risks to subjects are reasonable in relation to anticipated benefits.
The Belmont principle of beneficence requires that:
To all human subjects research that uses PHI without an authorization from the data subject.
The HIPAA "minimum necessary" standard applies...
Researcher
The PHS regulations about financial conflict of interests require which party to disclose significant financial conflicts of interest?
False
The federal regulations at 45 CFR 46 provide additional protections for subjects who are workers/employees to protect them from potential risks of harm.
All research funded by HHS
The provisions of Subpart D, of the HHS regulations, Additional Protections for Children Involved as Subjects in Research apply to:
Provide parents certain rights over their children's educational records.
The purpose of the Family Educational Rights and Privacy Act (FERPA) is to:
"Tastes, Ties, and Time (T3)" study (2006-2009)
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?
For all human subjects research that uses PHI without an authorization from the data subject, except for limited data sets.
Under HIPAA, a "disclosure accounting" is required:
Inherent controls
What is the term for management controls that are built in to a research study (for example, independent data analysis)?
Risks are specific to time, situation, and culture.
What statement about risks in social and behavioral sciences research is most accurate:
The researcher cannot control what participants repeat about others outside the group.
When a focus group deals with a potentially sensitive topic, which of the following statements about providing confidentiality to focus group participants is correct?
True
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.
must be more detailed for disclosures that involve fewer than 50 subject records.
When required, the information provided to the data subject in a HIPAA disclosure accounting ...
All of the above
When workers are asked to participate in a research study, vulnerabilities related to the subject's employment may include:
The Family Educational Rights and Privacy Act.
Which federal regulation or law governs how researchers can obtain data about subjects' disciplinary status in school from academic records?
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 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 researcher proposes to join a moderated support group for cancer survivors posing as a survivor. She plans to insert comments to see how the members respond.
Which of the following on-line research strategies raises the most concerns regarding the ethical principle of respecting the autonomy of research subjects and the corresponding federal regulations requiring informed consent?
Officials of the institution may overrule an IRB approval.
Which of the following statements about the relationship between an institution and the institution's IRB(s) is correct?
Federal regulations do not require the documentation of minors' assent.
Which of the following statements most accurately describes the requirement for the documentation of minors' assent to participate in research?
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.
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?
Public behavior
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:
There was neither a violation of privacy nor a breach of confidentiality.
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?
Both the magnitude (or severity) and the probability (or likelihood) of harm.
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:
This research would be eligible for exemption because the researcher is not interacting with the children and the playground is a public setting.
A researcher wants to observe preschoolers at a local public playground to evaluate levels of cooperation. The researcher will not interact with the children or record information in such a manner that the identity of the subjects can be readily ascertained. Which of the following statements is true?
Experience emotional or psychological distress.
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:
It may be difficult for the researcher to appear neutral, as the researcher may have an interest in the research's success
A researcher's membership on an advisory board with an organization sponsoring research can create a COI because:
justice
According to the Belmont Report, the requirement that the benefits and burdens of the research are equitably distributed, expresses the principle of:
The research falls into one of eight categories of research activity described in the regulations.
According to the federal regulations, research is eligible for exemption, if:
A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem-solving behaviors.
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.
According to the federal regulations, which of the following studies meets the definition of research with human subjects?
An experiment is proposed on the relationship between gender-related stereotypes in math and the subsequent performance by males and females on math tests.
According to the federal regulations, which of the following studies meets the definition of research with human subjects?
All of the above are correct
Additional protections researchers can include in their practice to protect subject privacy and data confidentiality include:
A study on the efficacy of a behavioral intervention for smoking cessation that involves both adults and teenagers (who are underage to purchase tobacco) in the United States
Identify the example of when situation and time are key to assessing risk of harm in a research study: