CITI questions

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?

Justice

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 studies would need IRB approval?

Studies collecting identifiable information about living individuals.

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.

Your informed consent form must describe _______.

All foreseeable risks and discomforts.

According to the federal regulations, which of the following studies meets the definition of research with human subjects? part 5

An experiment is proposed on the relationship between gender-related stereotypes in math and the subsequent performance by males and females on math tests.

In the U.S., the first federal regulations for human subjects research began in 1981 with the codification of the ________.

Common Rule

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.

A medical record is an example of:

private 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.

According to the federal regulations, which of the following studies meets the definition of research with human subjects? part 3

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

The Belmont principle of beneficence requires that:

Risks to subjects are reasonable in relation to anticipated benefits.

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

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.

Which type of IRB review does not require an IRB approval but does require a determination by an individual designated with that task (such as an IRB member or experienced staff person)?

Exempt

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 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

Under the U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) regulations, what is the Institutional Review Board (IRB) charged with? Select all that apply.

- Protecting the rights and welfare of human subjects.- Assuring that researchers follow all applicable institutional policies and federal regulations related to research with human subjects.- Reviewing subject recruitment materials and strategies.

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.

According to the federal regulations, which of the following studies meets the definition of research with human subjects? part 2

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.

Identify one way faculty researchers can possibly avoid undue influence of student subjects?

Avoid recruiting their own students in the research

A student is conducting a research project that involves the use of a survey. The survey asks subjects about their highest level of education, political affiliation, and views on various social issues. The student will not collect identifiable information. This study would be subject to which type of review?

Determination for Exemption

A student plans on interviewing 15 principals in neighboring high schools. The student plans to collect data about the personal experiences the principals have had with disruptive students, including the types of disciplinary actions that were taken (including decisions they may have personally made) and their feelings or thoughts regarding whether those actions were appropriate. The research data collected could have an impact on the principals' careers. The student will collect identifiers. This study would be subject to which type of review?

Convened Review

A graduate student needs to conduct a research project for her master's thesis. She is interested in the types of junk food available to the public. She plans to go to the local convenience stores and ask the owners what types of junk food the store normally stocks, and which are the biggest sellers. She will not collect identifiers. This study would be subject to which type of review?

Not Human Subjects

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..

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