CITI Training
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.
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.
The only type of trial for which FDA regulations mandate a DMC is:
A trial of emergency research using an exception from the informed consent requirement
Parental notification, in lieu of active parental permission, is allowed when:
An IRB has approved a waiver of the requirement for parental permission.
A risk mitigation plan might include
Criteria for reducing a subject's medication dose
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.
Which of the following statements about IRBs and DSMBs is true?
They have overlapping responsibilities for trial oversight
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 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 would be eligible for exemption because the researcher is not interacting with the children and the playground is a public setting.
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 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.
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.
The FDA regulations governing disclosure of individual COIs require:
Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies
To minimize potential risks of harm, a researcher conducting an on-line survey can:
Design the survey so that no direct or indirect identifiers are collected.
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.
What is the term for management controls that are built in to a research study (for example, independent data analysis)?
Inherent controls
Risk of harm in social and behavioral sciences generally fall in three categories, which are:
Invasion of privacy, breach of confidentiality, and study procedures
When an IRB is reviewing a research study and they are considering if a potential subject population is vulnerable, they should consider:
Is there a power differential between researchers and subjects?
DSMB meetings should be held
It depends
According to the Belmont Report, the requirement that the benefits and burdens of the research are equitably distributed, expresses the principle of:
Justice
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.
DSMB members should have
No significant conflicts of interest
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.
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
A medical record is an example of:
Private information
The type of member expertise needed on almost all DSMBs includes:
Statistics
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
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 Subpart D, research with children may be eligible for exemption under Category 2 when:
The research involves the use of educational tests
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.
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 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.
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 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.
What statement about risks in social and behavioral sciences research is most accurate:
Risks are specific to time, situation, and culture.
The Belmont principle of beneficence requires that:
Risks to subjects are reasonable in relation to anticipated benefits.
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 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.
: A DSMP includes a safety monitoring plan and what other component?
Data management plan
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.
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.
False
DSMBs are typically needed:
For all randomized trials when interim efficacy and/or safety comparisons are planned
A researcher conducting behavioral research collects individually identifiable sensitive information about illicit drug use and other illegal behaviors by surveying college students. The data are stored on a laptop computer without encryption, and the laptop computer is stolen from the researcher's car on the way home from work. This is an unanticipated problem that must be reported because the incident was (a) unexpected (in other words, the researchers did not anticipate the theft); (b) related to participation in the research; and (c) placed the subjects at a greater risk of psychological and social harm from the breach in confidentiality of the study data than was previously known or recognized. According to OHRP, this unanticipated problem must be reported to the IRB in which timeframe?
Promptly
The primary purpose of a Certificate of Confidentiality is to:
Protect identifiable research information from compelled disclosure.
The PHS regulations about financial conflict of interests require which party to disclose significant financial conflicts of interest?
Researcher
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
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.
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.
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.
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 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.
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.
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
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
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
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
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
Provide potential subjects with information at the appropriate reading comprehension level.
Securing a Certificate of Confidentiality
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
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.
Confidentiality of the interim results of a randomized trial is important because:
Revealing interim results may affect the conduct of the study and lead to biased results
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 researcher submits a study to the IRB that proposes to evaluate a new after-school on-line tutoring program for middle-school students in a local school district examining the effect on student grades. She proposes to perform this assessment at the school that her children attend, because she is familiar with the school district. Students may use either their personal smartphone or computer to participate in the program. This study might be determined to be violating which principle of the Belmont Report?
Justice
