CITI Training

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

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 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 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.

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

Recruiting into research ...

Can qualify as an activity "preparatory to research," at least for the initial contact, but data should not leave the covered entity.

Data are made anonymous by

Destroying all identifiers connected to the data.

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 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

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.

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.

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.

If research in a private school is directly funded by the Department of Education, then:

PPRA applies.

What statement about risks in social and behavioral sciences research is most accurate:

Risks are specific to time, situation, and culture.

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)

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.

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.

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.

An example of an institutional COI is:

An industry sponsor pays for the construction of a new research laboratory at the organization

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.

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

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.

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

HIPAA's protections for health information used for research purposes...

Supplement those of the Common Rule and FDA.

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.

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.

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 HIPAA authorization has which of the following characteristics:

Uses "plain language" that the data subject can understand, similar to the requirement for an informed consent document.

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.

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.

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.

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

HIPAA includes in its definition of "research," activities related to:

Development of generalizable knowledge.

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.

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 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.

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

As part of the consent process, the federal regulations require researchers to:

Provide potential subjects with information at the appropriate reading comprehension level.

Census data (the final report as published by the Census Bureau) is an example of:

Public information

Which of the following are the three principles discussed in the Belmont Report?

Respect for Persons, Beneficence, Justice

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

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 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.