Which of the following are the three principles discussed in the Belmont Report?
Respect for Persons, Beneficence, 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.
All of the following are true regarding the Belmont Report, EXCEPT:
The Belmont Report indicates that it is necessary to rigorously avoid conflicts of interest.
The researcher’s failure to protect research subjects from deductive disclosure is the primary ethical violation in which of the following studies?
Harvard “Tastes, Ties, and Time (T3)” study (2006-2009)” study
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.
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.
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 Tuskegee Study of Untreated Syphilis in the Negro Male.
According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of:
Justice.
The Belmont Principle of beneficence requires that
Potential benefits justify the risks of harm.
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.
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
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
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.
IRB continuing review of an approved protocol must:
Occur at least annually
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 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 you, you waive the right to legal redress for any research-related injuries
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.
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.
As part of the consent process, the federal regulations require researchers to:
Provide potential subjects with information at the appropriate reading comprehension level.
Data are made anonymous by
Destroying all identifiers connected to the data.
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.
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.
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.
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.
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
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
Which is an example of a situation where deferential vulnerability might be a factor?
A physician recruiting his patients
Which is true of inducements in research?
Inducements constitute an “undue influence” if they alter a potential subject’s decision-making processes, such that they do not appropriately weigh the risk-benefit relationship of the research.
Subjects with a serious illness may be at risk for exploitation since they may be desperate for a possible cure. This is an example of
Medical Vulnerability
The most important ethical concerns related to conflicts of interest in research are:
Ensuring the objectivity of research and the protection of human subjects
Current NIH rules require investigators to disclose details regarding financial conflicts of interest to:
Designated institutional officials
The 1998 FDA regulations for requiring disclosure of significant financial interest reflect which threshold:
Any equity interest in a publicly held company that exceeds $50,000
A financial conflict of interest could involve:
Receiving stock in a company funding your research.
A situation in which financial or other personal considerations have the potential to compromise or bias professional judgment and objectivity is an example of:
Conflict of Interest
NBAC proposed a concept of vulnerability in research based on features of potential subjects or of their situation. Which of the following was NOT included as possibly leading to vulnerability?
High potential for individual benefit from participating in research
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
Significant financial interest, as defined by the 2011 final rule that amended Public Health Service (PHS) regulations on Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F) and Responsible Prospective Contractors (45 C.F.R. Part 94), include(s) (Check all that apply):
– Equity/stock interests (regardless of value) in a non-publicly traded company.
– Intellectual property rights upon receipt of income related to such rights.
– Consulting payments in excess of $5,000.
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