CITI Program Modules
Which of the following are the three principles discussed in the Belmont Report?
Respect for Persons, Beneficence, Justice
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
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
A researcher wants to contact former prisoners who are now on parole. She wants to study the difficulty of obtaining employment based on whether the subjects have been convicted of felony versus misdemeanor crimes. She needs to:
Do nothing in regards the Subpart C because the research does not meet the criteria for prison research -- individuals on parole are not considered prisoners. The definition applies to both minors and adults.
Which example of research with prisoners would be allowable under the regulations?
Examining age at first arrest as a predictor of adult criminal history.
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?
According to the Belmont Report, the requirement that the benefits and burdens of the research are equitably distributed, expresses the principle of:
Justice
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.
A graduate student wants to examine the effect of print media versus televised media on individuals' position on several social issues. The superintendent of a local work release facility, a family friend, will allow the graduate student access to the prison population to help her quickly accrue subjects. The student's IRB should:
Not approve this project because the prisoners are merely a population of convenience for the student.
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.
According to the federal regulations, which of the following studies meets the definition of research with human subjects?
A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem-solving behaviors.
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 the 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 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?
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.
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.
Additional protections researchers can include in their practice to protect subject privacy and data confidentiality include:
All of the above
The provisions of Subpart D, of the HHS regulations, Additional Protections for Children Involved as Subjects in Research apply to:
All research funded by HHS
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.
An example of an institutional COI is:
An industry sponsor pays for the construction of a new research laboratory at the organization
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 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
Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects?
Determining that the study has a maximization of benefits and a minimization of risks.
Which of the following types of information may schools disclose without consent from the parent or student to a researcher at a local university?
Directory information
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.
Researchers must report potential unanticipated problems that involve risks to others directly to the:
Institutional Review Board (IRB)
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.
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.
No later than the time of proposal submission
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 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.
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 most helpful:
Obtain a waiver of documentation of informed consent.
According to the federal regulations, human subjects are living individuals about whom an investigator conducting research obtains information through interaction or intervention with the individual, and uses, studies, or analyzes the information; or:
Obtains, uses, studies, analyzes, or generates identifiable private information.
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.
Which of the following studies is linked most directly to the establishment of the National Research Act in 1974 and ultimately to the Belmont Report and federal regulations for human subject protection?
PHS Tuskegee Study
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.
The Belmont Report's principle of respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second that:
Persons with diminished autonomy are entitled to protection.
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.
Researchers designing online studies should consider the following with respect to participant protections.
Re-identification methods are unique to internet-based research.
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.
If the researcher 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)?
Research about aptitude testing
The PHS regulations about financial conflict of interests require which party to disclose significant financial conflicts of interest?
Researcher
Which of the following statements about prison research is true?
Researchers may study the effects of privilege upgrades awarded by the prison.
The Belmont principle of beneficence requires that:
Risks to subjects are reasonable in relation to anticipated benefits.
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
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.
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.
According to Subpart D, research with children may be eligible for exemption under Category 2 when:
The research involves the use of educational tests.
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.
Which scenario best describes a researcher making thoughtful considerations in the design of their informed consent process on an online study?
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."
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?
This research will be eligible for exemption because the researcher is not interacting with the children and the playground is a public setting.
According to OHRP, a problem is an "unanticipated problem" when it meets which of the following criteria:
Unexpected, related or possibly related to the research, suggests the research puts subjects or others are greater risk
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.
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 peer review process can create conflicts of interest because the choice of who reviews a potentially publishable project may show:
There may be bias by the peer reviewer as to the area of research
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 at the Big State University IRB?
Will the researchers have collaborators at the research site abroad?
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
The primary purpose of a Certificate of Confidentiality is to:
Protect identifiable research information from compelled disclosure.
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.
What consideration should researchers take into account when designing an online study that presents participants with misleading information?
Researchers cannot guarantee that participants reached the end of the study, and read and understood the debrief.
A medical record is an example of:
Private information
