CITI course answers

What type of expertise might be particularly helpful for an IRB reviewing big data research?

An employee from the organization's IT department who is experienced with levels of data security protections

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

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.

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.

Concerning big data research with traditional research, federal regulations:

Do not specifically address big data research or differentiate it from traditional research

In assessing this consideration, an IRB's determination may hinge on whether the information obtained by a big data researcher is individually identifiable and private.

Does the big data project involve "human subjects?"

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

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 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.

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.

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

According to the federal regulations, which of the following studies meets the definition of research with human subjects?

A developmental psychologist videotapes interactions between groups of toddlers and their caregivers to determine which intervention methods most effectively manage aggression.

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.

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.

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

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

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 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.

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

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.

Big data can be:

Predictive, prescriptive, and descriptive

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

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

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

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.

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.

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.

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.

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.