PSY 2307: Research Methods in Psych

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.

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

Avoid recruiting their own students in the research

Which of the following brought increased public attention to the problems with the IRB system?

Death of Research Subject (Jesse Gelsinger)

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

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

The National Research Act of 1974

Established the National Commission.

How long is an investigator required to keep consent documents, IRB correspondence, and research records?

For a minimum of three years after completion of the study

Which of the following was the result of the Beecher article?

Realization that ethical abuses are not limited to the Nazi regime

A subject in a clinical research trial experiences a serious, unanticipated adverse drug experience. How should the investigator proceed, with respect to the IRB, after the discovery of the adverse event occurrence?

Report the adverse drug experience in a timely manner, in keeping with the IRB's policies and procedures, using the forms or the mechanism provided by the IRB.

Informed consent is considered an application of which Belmont principle?

Respect for Persons

A study was submitted to the IRB designed to evaluate the effect of background noise on an individual's ability to concentrate and answer questions. The IRB approved the study and consent form. The consent form includes all the required information. The use of a consent form is an example of the Belmont principle of:

Respect for persons

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

The Belmont principle of beneficence requires that:

Risks to subjects are reasonable in relation to anticipated benefits.

Amendments involving changes to IRB-approved protocols do NOT need prior IRB approval if:

The changes must be immediately implemented for the health and well-being of the subject.

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

Where could student researchers and/or student subjects find additional resources regarding the IRB approval process? Select all that apply.

- Faculty Advisor/Research Mentor - IRB Office

The use of prisoners in research is a concern under the Belmont principle of Justice because:

Prisoners may not be used to conduct research that only benefits the larger society

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 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

IRB continuing review of a greater than minimal risk approved protocol that is currently enrolling subjects must:

Occur at least annually.

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

According to federal regulations, which of the following best describes when expedited review of a new, proposed study may be used by the IRB?

The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulations

Issued in 1974, 45 CFR 46 raised to regulatory status:

US Public Health Service Policy

Which of the following is included in the Nuremberg Code:

Voluntary consent