Professional & Biommedical Ethics
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.
The internet can be used as a research tool or as the object of a study. Which of the following examples best describes an investigator using the internet as a research tool?
An investigator uses his Facebook wall to post a URL link to a survey he is hosting on SurveyMonkey.
The NBAC looks at characteristics individuals might have that would prevent them from being able to provide voluntary informed consent. The traits may be thought of as falling into six broad areas: cognitive or communicative, institutional, deferential, medical, economic, and social. Prospective research subjects who are not able to comprehend information, deliberate, and make decisions about participation in a proposed research study have a:
Cognitive or communicative vulnerability
Which of the following is true about collaborations?
Collaborations can provide an opportunity for senior researchers to mentor junior colleagues.
Which of the following is true about collaboration and its effects on research productivity?
Communication and coordination can improve productivity
Data are made anonymous by
Destroying all identifiers connected to the data.
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
Institutions are required by the U.S. Public Health Service to do which of the following:
Evaluate whether a significant financial interest is related to an investigator's research and constitutes a financial conflict of interest
Which of the following is the most important factor in determining who should be entitled to authorship?
Guidelines from professional organizations and journals.
The age of majority in international research is determined by the
Laws, customs, and norms in the area 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
What procedures must be described in an agreement called an "assurance of compliance" with a U.S. federal agency?
Procedures in place that ensure that subjects will be protected in a manner commensurate with the Common Rule, including review by an independent committee comparable to an IRB.
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
Single-blind peer review typically refers to:
The authors not knowing the identity of the reviewers.
Which of the following financial conflict of interest information must be made available by institutions on a public website or within five business days upon request?
The financial conflicts of interest of senior/key personnel on projects funded by the U.S. Public Health Service
Which of the following financial conflict of interest information must be made available by institutions on a public website or within five business days upon request?
The financial conflicts of interest of senior/key personnel on projects funded by the U.S. Public Health Service.
The usual first phase of handling a research misconduct allegation is called:
The inquiry
Which of following is most likely to own the data resulting from a research project supported by federal funds?
The institution which receives the federal funds.
Which of the following most accurately describes the responsibilities of mentors in the mentor-trainee relationship?
The mentor's role encompasses a number of responsibilities, including being available to the trainee.
Many institutions have an office where trainees and others can discuss work conflicts and other matters confidentially. What is the name of that office?
The office of the ombudsperson.
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 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 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.
According to OHRP, a problem is an "unanticipated problem" when it meets which of the following criteria:
Unexpected, related or possibly related to the research, suggests the research puts subjects or others at greater 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 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
Which of the following is the least important activity when protecting human subjects in international research?
Assessing transportation conditions
The most effective way to promote responsible data management is to:
Involve all members of the research team while developing a management plan.
When an IRB is reviewing a research study and they are considering if a potential subject population is vulnerable, they should consider:
Is there a power differential between researchers and subjects?
If research in a private school is directly funded by the Department of Education, then:
PPRA applies.
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.
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.
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 specific Department of Health and Human Services (HHS) regulations that apply to research with children are known as:
Subpart D: Additional Protections for Children Involved as Subjects in Research
Risk of harm in social and behavioral sciences generally fall in three categories, which are:
Invasion of privacy, breach of confidentiality, and study procedures
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.
Researchers endeavoring to conduct an on-line study should consider that there are some potential risks of harm to subjects unique to internet-based research. One of these risks is:
Individuals may post private identifiable information about themselves on-line without intending it to be public and available to researchers.
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.
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
According to the U.S. Public Health Service regulations, investigators are required to disclose travel sponsored or reimbursed by:
A publicly traded company.
Which of the following statements most accurately describes a mitigation report?
A report to the U.S. Public Health Service of efforts that will be taken by the institution to deal with any bias that was found in research conducted while there was an unreported financial conflict of interest.
According to the U.S. Public Health Service, which of the following would be considered a significant financial interest?
An equity interest valued at $5,000 owned by the investigator's spouse in a company that produces products related to the investigator's institutional responsibilities.
Which of the following statements regarding mentoring is true?
An individual does not need to have all of the recognized mentoring skills in order to provide mentoring.
The Royal Society of London developed the modern form of peer review primarily in order to:
Control the quality of published papers.
Which of the following is most likely be considered sensitive data?
Data from a survey on illegal drug use that includes the participant's name.
Which of the following statements most accurately describes the principle of beneficence?
Determining whether the benefits of a study have been maximized and the harms minimized.
Which of the following is true about interdisciplinary collaborations?
Different ideas about proof, evidence, and method can make interdisciplinary collaborations difficult.
The U.S. Public Health Service (PHS) requires institutions to:
Disclose their investigators' new financial conflicts of interest to the PHS awarding component within 60 days of discovering them.
Which of the following is most likely to improve the effectiveness of a collaboration?
Early planning and communication about expectations
According to the U.S. Public Health Service, a "significant financial interest" includes royalty income paid to an investigator and its disclosure is required
Except if that income is from the institution that currently employs the investigator.
A researcher proposes to conduct a study at a foreign site. The research has been determined to be exempt from the federal regulations by institutional policy. According to federal regulations, is review required at the foreign site?
If a proposed study qualifies for exemption, federal regulations do not require review at the foreign site where it will be conducted
According to the U.S. Public Health Service, the definition of the term "investigator":
Includes anyone involved in the conduct or reporting of research.
What is the term for management controls that are built in to a research study (for example, independent data analysis)?
Inherent controls
Which of the following statements is true regarding the reporting of outside interests and the management of conflicts?
Investigators must disclose their significant financial interests related to their institutional responsibilities and not just those related to a particular project.
Which of the following statements best describes the role of an IRB?
It is a committee that reviews different types of human subjects research.
Which of the following statements most accurately describes a fundamental feature of mentoring?
It is a mechanism to transmit ethical standards of professional conduct.
Which of the following most accurately describes fragmentary publication?
It refers to dividing a single project into more publications than warranted.
Subjects with a serious illness may be at risk for exploitation because they may be desperate for a possible cure. This is an example of:
Medical vulnerability
Which of the following statements most accurately describes the mentoring relationship?
Mentors can teach trainees about aspects of academic life that are not covered in textbooks.
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
Which of following most accurately describes when investigators pursuing U.S. Public Health Service funding are required to disclose their significant financial interests to their institution?
No later than the time of applying for funding.
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.
The main reason why federal agencies created financial conflicts of interest regulations is to:
Protect the integrity of research.
The purpose of the Family Educational Rights and Privacy Act (FERPA) is to:
Provide parents certain rights over their children's educational records.
If a subject has not been informed about the risks of participating in research, which is the primary ethical principle that has likely been violated?
Respect for persons
The three ethical principles discussed in the Belmont Report are:
Respect for persons, beneficence, and justice
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
Which of the following describes the main purpose of the regulatory system for the protection of human subjects?
The system is designed to uphold the ethical principles described in the Belmont Report.
Which of the following most directly describes an act of plagiarism?
Using text from a previously published source without attribution.
A graduate student wants to examine the effect of print media versus televised media on individuals' position on several social issues. The superintendent of a local work release facility, a family friend, will allow the graduate student access to the prison population to help her quickly accrue subjects. The student's IRB should:
Not approve this project because the prisoners are merely a population of convenience for the student.
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.
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
A researcher wants to contact former prisoners who are now on parole. She wants to study the difficulty of obtaining employment based on whether the subjects had been convicted of felony versus misdemeanor crimes. She needs to:
Do nothing in regards the Subpart C because the research does not meet the criteria for prison research -- individuals on parole are not considered prisoners. The definition applies to both minors and adults.
Which of the following are the three principles discussed in the Belmont Report?
Respect for Persons, Beneficence, Justice
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.
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
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 wishes to study generational differences in coping mechanisms among adults who experienced abuse as children. Adequate measures will be instituted to obtain informed consent and ensure that there is no breach of confidentiality. The most likely additional risk is that some subjects may:
Experience emotional or psychological distress
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.
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.
An example of an institutional COI is:
An industry sponsor pays for the construction of a new research laboratory at the organization
Which of the following is the most appropriate way to determine how authors should be listed on a publication?
All contributors should discuss the matter, preferably early on in a project and as the project evolves.
The provisions of Subpart D, of the HHS regulations, Additional Protections for Children Involved as Subjects in Research apply to:
All research funded by HHS
A reviewer's main responsibility is to:
Be professional and prompt.
Neither Subpart C (Prisoners) nor Subpart D (Children) applies to juveniles in the correctional systems because wardens of juvenile prisoners (unlike those for adult prisoners) act in loco parentis for juvenile offenders. This statement is false because:
Both subparts apply, as these individuals are under the legal age of consent and are incarcerated
Which of the following examples of using the internet to conduct research meets the federal definition of research with human subjects?
Conducting an on-line focus group with cancer survivors to determine familial support systems. The researcher also invites subjects' significant others to be a part of the focus group
Consent to participate in research is an ongoing process. Which of the following strategies would help ensure that participation in a survey about a sensitive personal topic remains voluntary throughout a study?
Designing the survey so that subjects are not forced to answer one question before going to the next.
Which strategy is the most likely to detect and prevent research misconduct?
Have research team members verify the progress of the research and the data collected periodically.
The primary aim of peer review of manuscripts is to:
Improve the quality of publications.
Which of the following most accurately describes falsification?
It involves inappropriately tampering with data or equipment
Which of the following most accurately describes a conflict of commitment?
It is a situation where outside activities might interfere with the obligations that individuals have to their primary employer.
Which of the following most accurately describes the practice of publishing similar content more than once?
It may be appropriate with the agreement of the relevant publishers and authors.
According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of:
Justice
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.
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.
If the research is subject to Subpart D, which of the following research activities with children would qualify for an exemption under Category 2 (research that includes educational tests, surveys, interviews, observation)?
Research about aptitude testing
The Office of Research Integrity's jurisdiction covers research misconduct relating to:
Research that has been funded by the U.S. Public Health Service.
If a case of research misconduct is suspected, what is typically considered to be the appropriate first step to take?
Seek advice from a trusted colleague or other entity such as an ombudsperson.
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 of the following methods could be considered a "best practice" in terms of informing respondents how their answers to an on-line survey about personal information will be protected?
The investigator uses the informed consent process to explain how respondent data will be transmitted from the website to his encrypted database without ever recording respondents' IP addresses, but explains that on the internet confidentiality cannot be absolutely guaranteed.
A researcher recently received $6,000 in consulting payments from a company that also sponsors one of the researcher's projects.
The typical disclosure threshold for PHS-funded projects is more than $5,000 in one entity.
A sociologist wants to study a culture that occurs in some women's prisons: "state families," in which individual prisoners take on certain roles within a group of like-minded prisoners. There is previous evidence that younger prisoners will use older inmates who play the roles of grandparents as a resource before they will turn to staff for help and advice. The lieutenant in charge of a dorm of long-term prisoners offers to gather volunteers to speak to the researcher and also offers to vouch for the integrity of the researcher. The use of this staff is:
Wrong and is prohibited; subject selection needs to be free from intervention by prison authorities or prisoners
Census data (the final report as published by the Census Bureau) is an example of:
Public information
Which of the following is the most effective way to manage access and promote security related to electronic data?
Require complex computer passwords.
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 accordance with to the U.S. Public Health Service (PHS) regulations, which of the following would be considered a significant financial interest?
A researcher recently received $6,000 in consulting payments from a company that also sponsors one of the researcher's projects.
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 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.
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 example of research with prisoners would be allowable under the regulations?
Examining age at first arrest as a predictor of adult criminal history.
The Belmont principle of beneficence requires that:
Potential benefits justify the risks of harm.
Which of the following most accurately describes appropriate authorship practice?
Researchers normally need to make a significant intellectual contribution to a project before they are listed as an author on a resulting publication.
Which of the following describes the most appropriate course of action that researchers should take as they prepare to leave their current institution for a new position?
Researchers should review their current institution's policies regarding data ownership.
According to Subpart D, research with children may be eligible for exemption under Category 2 when:
The research involves the use of educational tests
During the early Twentieth Century, peer review started to be applied to grant proposals in the United States. The main reason why this occurred was:
To provide a fairer mechanism for awarding grants.
A professor at Big State University proposes to study attitudes about obesity in Chile by giving subjects in Chile surveys to complete. Which is a question that the Big State University IRB should ask the researcher in order to determine if this study should be reviewed by a local Chilean IRB or ethics committee, as well as the Big State University IRB?
Will the researchers have collaborators at the research site abroad?
A researcher calls you stating that he plans to submit a proposal to the NIH for a human subjects research study. He wants to know at what point he and his study team must submit COI disclosures to comply with the PHS regulation.
No later than the time of proposal submission
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's membership on an advisory board with an organization sponsoring research can create a COI because:
It may be difficult for the researcher to appear neutral, as the researcher may have an interest in the research's success
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 is true?
The number of collaborations between academic institutions and industry has increased since the enactment of the Bayh-Dole Act.
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
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
