CITI Social & Behavioral Research-basic/refresher
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.
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 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.
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
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
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
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
If research in a private school is directly funded by the Department of Education, then:
PPRA applies.
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.
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.
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
Which of the following are the three principles discussed in the Belmont Report?
Respect for persons, beneficence, justice
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
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 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.
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.
Under HIPAA, a "disclosure accounting" is required:
For all human subjects research that uses PHI without an authorization from the data subject, except for limited data sets.
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 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:
Individuals may post private identifiable information about themselves on-line without intending it to be public and available to researchers.
What is the term for management controls that are built in to a research study (for example, independent data analysis)?
Inherent controls
Researchers must report potential unanticipated problems that involve risks to others directly to the:
Institutional Review Board (IRB)
Under HIPAA, "retrospective research" (a.k.a., data mining) on collections of PHI generally ...
Is research, and so requires either an authorization or meeting one of the criteria for a waiver of authorization.
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 as the Big State University IRB?
Will the researchers have collaborators at the research site abroad?
Which of the following is the least important activity when protecting human subjects in international research?
Assessing transportation conditions
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
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?
"Taste, Ties, and Time (T3)" study
According to the federal regulations, which of the following studies meets the definition of research with human subjects?
A cognitive psychologist enrolls undergraduate students...
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 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.
An example of an individual financial COI is:
A researcher's spouse holds equity in a publicly traded pharmaceutical company that is also the sponsor of the researcher's study.
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.
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...
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.
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 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 covered entity may use or disclose PHI without an authorization, or documentation of a waiver or an alteration of authorization, for all of the following EXCEPT:
Data that does not cross state lines when disclosed by the covered entity.
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
According to the Belmont Report, the requirement that the benefits and burdens of the research are equitably distributed expresses the principle of:
Justice
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.
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.
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.
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
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
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.
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 does not include human subjects as defined by the federal regulations.
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.
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.
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.
The HIPAA "minimum necessary" standard applies...
To all human subjects research that uses PHI without an authorization from the data subject.
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.
When required, the information provided to the data subject in a HIPAA disclosure accounting ...
must be more detailed for disclosures that involve fewer than 50 subject records.
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
