Citi Training, Assessing Risk - SBE, CITI Questions
Identify the following groups that are protected in the federal regulations (45 CFR 46), specifically in Subparts B, C, and D with additional protections:
Pregnant women, prisoners, children
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 at greater risk
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.
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.
Your informed consent form must describe _______.
All foreseeable risks and discomforts.
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
Parental notification, in lieu of active parental permission, is allowed when:
An IRB has approved a waiver of the requirement for parental permission.
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.
Identify the example of when situation and time are key to assessing risk of harm in a research study:
Asking women if they have had an abortion
Data are made anonymous by
Destroying all identifiers connected to the data.
Which is true of inducements in research?
Inducements constitute an "undue influence" if they alter a potential subject's decision-making processes, such that they do not appropriately weigh the risk-benefit relationship of the research.
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
According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of:
Justice
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
Subjects with a serious illness may be at risk for exploitation because they may be desperate for a possible cure. This is an example of:
Medical vulnerability
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 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.
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.
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 Belmont principle of beneficence requires that:
Potential benefits justify the risks of harm.
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
A medical record is an example of:
Private information
If the research 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
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.
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
Which is an example of a situation where deferential vulnerability might be a factor?
A physician recruiting his patients
The researcher's failure to protect research subjects from deductive disclosure is the primary ethical violation in which of the following studies?
"Tastes, Ties, and Time (T3)" study (2006-2009)
Where could student researchers and/or student subjects find additional resources regarding the IRB approval process? Select all that apply.
- Faculty Advisor/Research Mentor - IRB Office
Under the U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) regulations, what is the Institutional Review Board (IRB) charged with? Select all that apply.
- Protecting the rights and welfare of human subjects.- Assuring that researchers follow all applicable institutional policies and federal regulations related to research with human subjects.- Reviewing subject recruitment materials and strategies.
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.
Identify one way faculty researchers can possibly avoid undue influence of student subjects?
Avoid recruiting their own students in the research
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.
In the U.S., the first federal regulations for human subjects research began in 1981 with the codification of the ________.
Common Rule
A researcher is examining the quality of life for prisoners who are HIV-positive using surveys followed by interview. The IRB must ensure that:
Confidentiality of the prisoners' health status is maintained.
A student plans on interviewing 15 principals in neighboring high schools. The student plans to collect data about the personal experiences the principals have had with disruptive students, including the types of disciplinary actions that were taken (including decisions they may have personally made) and their feelings or thoughts regarding whether those actions were appropriate. The research data collected could have an impact on the principals' careers. The student will collect identifiers. This study would be subject to which type of review?
Convened Review
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 subject participates in a drug study because treatment is available at no or reduced cost, and he could not otherwise afford it. This is an example of:
Economic vulnerability
Which example of research with prisoners would be allowable under the regulations?
Examining age at first arrest as a predictor of adult criminal history.
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.
NBAC proposed a concept of vulnerability in research based on features of potential subjects or of their situation. Which of the following was not included as possibly leading to vulnerability?
High potential for individual benefit from participating in research
The primary purpose of a Certificate of Confidentiality is to:
Protect identifiable research information from compelled disclosure
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.
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
What statement about risks in social and behavioral sciences research is most accurate:
Risks are specific to time, situation, and culture.
Which of the following statements about prison research is true?
Researchers may study the effects of privilege upgrades awarded by the prison.
Which of the following are the three principles discussed in the Belmont Report?
Respect for Persons, Beneficence, Justice
A study was submitted to the IRB designed to evaluate the effect of background noise on an individual's ability to concentrate and answer questions. The IRB approved the study and consent form. The consent form includes all the required information. The use of a consent form is an example of the Belmont principle of:
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:
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:
Respect for persons
Which of the following studies would need IRB approval?
Studies collecting identifiable information about living individuals.
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 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?
The Public Health Service Study of Untreated Syphilis
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.
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.
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.
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?
Notify the IRB promptly and allow the subject to remain in the study while the IRB makes the determinations required by the regulations.
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.
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.
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
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 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.
