SOCIAL AND BEHAVIORAL RESEARCH
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:
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.
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.
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 types of information may schools disclose without consent from the parent or student to a researcher at a local university?
Directory information.
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
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.
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
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 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.
Asking women if they have had an abortion
Identify the example of when situation and time are key to assessing risk of harm in a research study:
Obtain a waiver of documentation of informed consent.
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:
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?
The research could not practicably be carried out without the waiver of consent.
In order to grant a waiver or alteration of the requirements of informed consent, an IRB must find what?
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.
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
The educational records are necessary for the educational official in question to perform their role as defined in the job description.
What is criteria for meeting the definition of "legitimate educational interest?"
A student who is 18 years of age or enrolled in a postsecondary institution.
What is meant by an "eligible student?"
Within 45 days
What is the period of time an educational institution has to respond to a request by an eligible student or parent to review an educational record?
Is there written permission to collect the data? Will the use of the data be for a legitimate educational interest? Will the disclosure be to another educational institution?
What three questions must an IRB include in its FERPA checklist?
Respect for Persons, Beneficence, Justice
Which of the following are the three principles discussed in the Belmont Report? Informed Consent, Institutional Assurance, Researcher Responsibility Privacy, Confidentiality, Equitable Selection of Subjects IRB Review, Federal Regulations, Declaration of Helsinki Respect for Persons, Beneficence, Justice
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)?
Ensuring that risks are reasonable in relationship to anticipated benefits
Which of the following is an example of how the principle of beneficence is applied to a study involving human subjects? Ensuring that the selection of subjects is fair Providing detailed information about the study to potential subjects Ensuring that subjects understand that participation is voluntary Ensuring that risks are reasonable in relationship to anticipated benefits
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:
A researcher proposes to conduct a study at a foreign site. The research has been determined to be exempt from the federal regulations by institutional policy. According to federal regulations, is review required at the foreign site?
If a proposed study qualifies for exemption, federal regulations do not require review at the foreign site where it will be conducted.
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
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.
Invasion of privacy, breach of confidentiality, and study procedures
Risk of harm in social and behavioral sciences generally fall in three categories, which are:
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.
The researcher will not be interacting/intervening with subjects and the data has no identifiers.
A researcher wants to conduct a secondary analysis using a Centers for Disease Control and Prevention (CDC) database that was collected by the agency solely for surveillance purposes from 1996-2006. The researcher did not participate in the initial collection of the date. The database is publicly available. The database does not include any identifiers. The IRB makes a determination that the individuals whose records will be reviewed do not meet the federal definition of human subjects. What consideration is relevant to the IRB's determination that this activity does not constitute research with human subjects?
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? The elderly Adults with decisional impairments College students Prisoners
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?
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?
Are the surveys ED-funded in whole or part?
Which of the following is a question an IRB must ask to ensure the research complies with PPRA? Are the surveys administered during class time? Does the research involve student assessments? Are the surveys ED-funded in whole or part? Is the research taking place in a secondary school?
Which of the following is the least important activity when protecting human subjects in international research?
Assessing transportation conditions
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?
Provide a summation of survey results, without the grades
A researcher is conducting a study of four graduate students enrolled in a unique university program. The foundation supporting the study wants a report that provides summary information about the students' outcomes, including their grades and survey responses. What would be the least risky option?
Provide potential subjects with information at the appropriate reading comprehension level.
As part of the consent process, the federal regulations require researchers to:
Distorting student IDs using an algorithm, so that researchers can conduct longitudinal studies
"Scrambling identifiers" refers to what procedure?
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:
FERPA prevents the school from providing the data because the researcher does not have prior parental consent
A researcher is conducting a study of students with special needs in a local school. The study requires the analysis of identifiable student performance data from the past five years. The researcher plans to publish the study results in a peer-reviewed journal and presenting them at conferences. This research could potentially help thousands of young students. Which of the following is true? FERPA allows the school to make an exception for any students over 13 years old The researcher is eligible for a waiver of parental consent given the study's importance to the field of education FERPA prevents the school from providing the data because the researcher does not have prior parental consent The researcher is not eligible for a FERPA waiver because the data are too recent
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.
Remove all direct identifiers from the data as soon as possible.
Additional safeguards that may be included in a social and behavioral study may include:
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.
The student's professor is collecting data for their own research.
An eligible student's educational record is generally not disclosed in situations where:
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 breach of confidentiality
An investigator obtains consent and HIPAA authorization from subjects to review their medical records and HIV status. He plans to go back to the medical record, so the HIV status information is stored along with the subject identifiers in a database that he keeps on his laptop computer. His laptop is stolen. This incident constitutes:
The NBAC looks at characteristics individuals might have that would prevent them from being able to provide voluntary informed consent. The traits may be thought of as falling into six broad areas: cognitive or communicative, institutional, deferential, medical, economic, and social. Prospective research subjects who are not able to comprehend information, deliberate, and make decisions about participation in a proposed research study have a:
Cognitive or communicative vulnerability
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 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's membership on an advisory board with an organization sponsoring research can create a COI because:
It may be difficult for the researcher to appear neutral, as the researcher may have an interest in the research's success
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.
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.
Which of the following activities constitutes engagement in research?
Obtaining informed consent and conducting research interviews.
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 purpose of the Family Educational Rights and Privacy Act (FERPA) is to:
Provide parents certain rights over their children's educational records.
Persons with diminished autonomy are entitled to protection.
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:
Risks to subjects are reasonable in relation to anticipated benefits.
The Belmont principle of beneficence requires that:
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 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.
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
School counselors and university admins
This group was originally opposed to FERPA:
The HIPAA "minimum necessary" standard applies...
To all human subjects research that uses PHI without an authorization from the data subject.
Studies that focus on improving instruction
Under FERPA, which of the following types of studies are eligible for an exception from consent? Studies that focus on improving instruction Studies that focus on student achievement Studies that involve school teachers and students Studies that involve minimal 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.
Student educational records in paper and electronic form
What are student administrative data?
Suppressing, blurring, and masking
What are the three different ways to reduce the possibility of an unauthorized PII disclosure?
A federal law that seeks to protect the rights of parents and students in ED-funded programs
What is PPRA?
Family Policy Compliance Office (FPCO)
Which federal agency oversees the enforcement of FERPA?
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.
Destroying all identifiers connected to the data.
Data are made anonymous by
The PHS regulations about financial conflict of interests require which party to disclose significant financial conflicts of interest?
Researcher
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
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:
What is the term for management controls that are built in to a research study (for example, independent data analysis)?
Inherent controls
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:
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 had 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.
Justice
According to the Belmont Report, the requirement that the benefits and burdens of the research are equitably distributed, expresses the principle of:
Obtains, uses, studies, analyzes, or generates identifiable private information.
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:
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 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
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.
The risk of disclosure of students' information reported in that cell
Which of the following is a risk associated with a small cell size?
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?
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?
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:
A developmental psychologist videotapes interactions between groups of toddlers and their caregivers to determine which intervention methods most effectively manage aggression.
According to the federal regulations, which of the following studies meets the definition of research with human subjects? A researcher asks the director of a local free clinic about the number of patients in the last two years with newly diagnosed HIV/AIDS. A researcher conducts a linguistic study of comments posted on a local public blog. A developmental psychologist videotapes interactions between groups of toddlers and their caregivers to determine which intervention methods most effectively manage aggression. A researcher uses the Customs Office's passenger lists for ships bringing immigrants to the U.S. between 1820-1845 to track the numbers of immigrants from certain ethnic groups.
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? 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 collection of data, by a playground designer hired by the superintendent of schools, about the physical dimensions of school playgrounds, presence of fencing, and the kinds of equipment currently provided. An analysis of aggregate data comparing statewide high school graduation rates provided by the State Department of Public Instruction, using county tax information. A feasibility study for implementing a year-round school program, focusing on economic issues such as facilities utilization and transportation costs.
If you're unsure about the particulars of HIPAA research requirements at your organization or have questions, you can usually consult with:
An organizational IRB or Privacy Board, privacy official ("Privacy Officer"), or security official ("Security Officer"), depending on the issue.
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.
Any metadata that an online tool produces (for example, data about a student's usage of a tool, or how much time it took them to take an assessment or look at a video) if they are not tied to any identifying information
Content from online educational tools that FERPA does not protect includes:
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
Institutions have the liberty to define what they consider directory information within certain guidelines.
Which of the following is correct? Colleges and universities must comply with an eligible student's request to change information in their educational record. Institutions have the liberty to define what they consider directory information within certain guidelines. College professors can provide student transcripts to parents. "Treatment records" for a student being treated by a school psychologist are usually protected under the Health Insurance Portability and Accountability Act (HIPAA).
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? Department chairs can overturn an IRB disapproval. Institutional priorities take precedence over all IRB determinations. Officials of the institution may overturn an IRB disapproval. Officials of the institution may overrule an IRB approval.
PHS Tuskegee Study
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 Stanford Prison Experiment (Zimbardo) Tearoom Trade Study (Humphreys) The "Tastes, Ties, and Time (T3)" study
