Multiple Choice Questions

Provide potential subjects with information at the appropriate reading comprehension level.
  • As part of the consent process, the federal regulations require researchers to:
  • The primary purpose of a Certificate of Confidentiality is to:
  • Which of the following is true regarding the U.S. Federal Research Misconduct Policy?
  • Which of the following most accurately describes the practice of ghost authorship?
Risks are specific to time, situation, and culture.
  • When required, the information provided to the data subject in a HIPAA disclosure accounting ...
  • What statement about risks in social and behavioral sciences research is most accurate:
  • Which of the following most accurately describes the practice of ghost authorship?
  • Which of the following is the most effective strategy for preventing research misconduct?
It is a situation where the individual who wrote the manuscript is not listed as an author.
  • Which of the following is the most effective strategy for preventing research misconduct?
  • Which of the following brought increased public attention to the problems with the IRB system?
  • Which of the following most accurately describes the practice of ghost authorship?
  • Risk of harm in social and behavioral sciences generally fall in three categories, which are:
Falsification
  • Which type of research misconduct most likely occurred if someone intentionally removes data points from the data set in order to generate a deceptive conclusion?
  • 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:
  • According to the U.S. Federal Research Misconduct Policy, falsification involves:
  • In considering NBAC's analytic approach, an otherwise competent person who is acutely ill might be considered at especially high risk of harm for:
To have a misconduct finding, the action must have been committed intentionally, knowingly, or recklessly.
  • Which of the following most accurately describes the practice of ghost authorship?
  • Which of the following brought increased public attention to the problems with the IRB system?
  • Which of the following is true regarding the U.S. Federal Research Misconduct Policy?
  • Which of the following is the most effective strategy for preventing research misconduct?
Asking women if they have had an abortion
  • When required, the information provided to the data subject in a HIPAA disclosure accounting ...
  • Identify the example of when situation and time are key to assessing risk of harm in a research study:
  • Which of the following is the most effective strategy for preventing research misconduct?
  • Which of the following are the three principles discussed in the Belmont Report?
Although all of these are related to the problems with the IRB system, the death of a research subject (Jesse Gelsinger) was what received public attention.
  • 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)?
  • Risk of harm in social and behavioral sciences generally fall in three categories, which are:
  • Which of the following brought increased public attention to the problems with the IRB system?
  • Which of the following most accurately describes the practice of ghost authorship?
Research is only eligible for exemption if all the activities associated with the research fall into one of eight categories of activities described in the federal regulations. The regulations do allow some research with children to be exempt (although institutional policy may not). The duration of the study and the experience of the researcher are not criteria for determining eligibility for exemption.
  • According to the federal regulations, research is eligible for exemption, if:
  • According to the U.S. Federal Research Misconduct Policy, fabrication involves:
  • According to the federal regulations, which of the following studies meets the definition of research with human subjects?
  • Informed consent is considered an application of which Belmont principle?
Situational cognitive vulnerability
  • When an IRB is reviewing a research study and they are considering if a potential subject population is vulnerable, they should consider:
  • IRB continuing review of a greater than minimal risk approved protocol that is currently enrolling subjects must:
  • In considering NBAC's analytic approach, an otherwise competent person who is acutely ill might be considered at especially high risk of harm for:
  • Identify the example of when situation and time are key to assessing risk of harm in a research study:
The two main criteria used by NSF to evaluate a grant proposal are the intellectual merit and broader impacts of the proposal.
  • Which of the following is true regarding the U.S. Federal Research Misconduct Policy?
  • 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 two main criteria that the National Science Foundation (NSF) uses to evaluate grant proposals are:
  • Under HIPAA, "retrospective research" (a.k.a., data mining) on collections of PHI generally ...
Can qualify as an activity "preparatory to research," at least for the initial contact, but data should not leave the covered entity.Comment It is still permissible under HIPAA to discuss recruitment into research with patients for whom such involvement might be appropriate. This common practice is considered to fall within the definition of treatment, at least when the conversation is undertaken by one of the patient's healthcare providers. If the contact will be made by someone other than the patient's healthcare provider, permission will be required.
  • Recruiting into research ...
  • According to the authors, there are four common abuses that historically are described as giving rise to vulnerability. Which response below contains the correct four?
  • According to the federal regulations, research is eligible for exemption, if:
  • According to the U.S. Federal Research Misconduct Policy, fabrication involves:
There was neither a violation of privacy nor a breach of confidentiality
  • 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:
  • When an IRB is reviewing a research study and they are considering if a potential subject population is vulnerable, they should consider:
  • 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 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?
Persons with diminished autonomy are entitled to protection.
  • When required, the information provided to the data subject in a HIPAA disclosure accounting ...
  • What statement about risks in social and behavioral sciences research is most accurate:
  • Risk of harm in social and behavioral sciences generally fall in three categories, which are:
  • 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:
The Nuremberg Code included the requirement of the voluntary consent of subjects. While all of the choices are valid ethical concerns, none of the other choices were included in the Nuremberg Code.
  • Which of the following most accurately describes the practice of ghost authorship?
  • Which of the following brought increased public attention to the problems with the IRB system?
  • Which of the following is the most effective strategy for preventing research misconduct?
  • Which of the following is included in the Nuremberg Code:
An organizational IRB or Privacy Board, privacy official ("Privacy Officer"), or security official ("Security Officer"), depending on the issue.
  • According to the federal regulations, which of the following studies meets the definition of research with human subjects?
  • Which of the following brought increased public attention to the problems with the IRB system?
  • According to federal regulations, which of the following best describes when expedited review of a new, proposed study may be used by the IRB?
  • If you're unsure about the particulars of HIPAA research requirements at your organization or have questions, you can usually consult with:
For all human subjects research that uses PHI without an authorization from the data subject, except for limited data sets.
  • Which of the following is true regarding research misconduct?
  • Under HIPAA, a "disclosure accounting" is required:
  • Issued in 1974, 45 CFR 46 raised to regulatory status:
  • The HIPAA "minimum necessary" standard applies...
Respect for Persons
  • Census data (the final report as published by the Census Bureau) is an example of:
  • Which of the following are the three principles discussed in the Belmont Report?
  • Informed consent is considered an application of which Belmont principle?
  • According to the federal regulations, research is eligible for exemption, if:
Occur at least annually.
  • 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:
  • How long is an investigator required to keep consent documents, IRB correspondence, and research records?
  • IRB continuing review of a greater than minimal risk approved protocol that is currently enrolling subjects must:
  • Identify the example of when situation and time are key to assessing risk of harm in a research study:
To all human subjects research that uses PHI without an authorization from the data subject.
  • Under HIPAA, a "disclosure accounting" is required:
  • The two main criteria that the National Science Foundation (NSF) uses to evaluate grant proposals are:
  • The primary purpose of a Certificate of Confidentiality is to:
  • The HIPAA "minimum necessary" standard applies...
Identifiable health information that is created or held by covered entities and their business associates.
  • Which of the following is true about the management of conflicts of interest?
  • HIPAA protects a category of information known as protected health information (PHI). PHI covered under HIPAA include
  • 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?
  • HIPAA's protections for health information used for research purposes...
If the only identifier collected in the course of a study would be the signature on the consent document and the principal source of harm would be a breach of confidentiality disclosing one's participation in the study, a waiver of documentation of informed consent should be sought. With such a waiver, the informed consent process could be conducted verbally with no written evidence of the subject's participation in the research.
  • 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?
  • If you're unsure about the particulars of HIPAA research requirements at your organization or have questions, you can usually consult with:
  • 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)?
  • 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:
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.Comment The most appropriate action for the investigator to take is to report the adverse drug experience in a timely manner using the forms provided by the institution.
  • 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:
  • According to the authors, there are four common abuses that historically are described as giving rise to vulnerability. Which response below contains the correct four?
  • 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?
  • 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?
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
  • 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?
  • Which of the following is true about the management of conflicts of interest?
  • A covered entity may use or disclose PHI without an authorization, or documentation of a waiver or an alteration of authorization, for all of the following EXCEPT:
  • HIPAA's protections for health information used for research purposes...
Physical control, coercion, undue influence, and manipulationComment There are four common abuses that historically are described as giving rise to vulnerability 1) physical control, 2) coercion, 3) undue influence, and 4) manipulation. These exist along a continuum of severity with physical control being the most severe and undue influence and manipulation being the least (Nelson and Merz 2002, V69-80). The other abuses- prejudice, neglect, and disrespect - should still be avoided in research.
  • According to the authors, there are four common abuses that historically are described as giving rise to vulnerability. Which response below contains the correct four?
  • According to federal regulations, which of the following best describes when expedited review of a new, proposed study may be used by the IRB?
  • According to the federal regulations, which of the following studies meets the definition of research with human subjects?
  • 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?
Is there a power differential between researchers and subjects?
  • When an IRB is reviewing a research study and they are considering if a potential subject population is vulnerable, they should consider:
  • In considering NBAC's analytic approach, an otherwise competent person who is acutely ill might be considered at especially high risk of harm for:
  • When required, the information provided to the data subject in a HIPAA disclosure accounting ...
  • What statement about risks in social and behavioral sciences research is most accurate:
Federal funding agencies typically rely on an institution to make the initial response to an allegation of research misconduct.
  • Which of the following are the three principles discussed in the Belmont Report?
  • Which of the following is the most effective strategy for preventing research misconduct?
  • Under HIPAA, a "disclosure accounting" is required:
  • Which of the following is true regarding research misconduct?
Data that does not cross state lines when disclosed by the covered entity.
  • HIPAA's protections for health information used for research purposes...
  • Which of the following is true about the management of conflicts of interest?
  • HIPAA protects a category of information known as protected health information (PHI). PHI covered under HIPAA include
  • A covered entity may use or disclose PHI without an authorization, or documentation of a waiver or an alteration of authorization, for all of the following EXCEPT:
must be more detailed for disclosures that involve fewer than 50 subject records.
  • What statement about risks in social and behavioral sciences research is most accurate:
  • When required, the information provided to the data subject in a HIPAA disclosure accounting ...
  • Which of the following is the most effective strategy for preventing research misconduct?
  • When an IRB is reviewing a research study and they are considering if a potential subject population is vulnerable, they should consider:
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?
  • HIPAA protects a category of information known as protected health information (PHI). PHI covered under HIPAA include
  • HIPAA's protections for health information used for research purposes...
  • Which of the following is true about the management of conflicts of interest?
The National Research Act of 1974 established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The identification of guidelines, ethical principles and regulations came as a result of the deliberations of the National Commission.
  • HIPAA's protections for health information used for research purposes...
  • Which of the following is true about the management of conflicts of interest?
  • A covered entity may use or disclose PHI without an authorization, or documentation of a waiver or an alteration of authorization, for all of the following EXCEPT:
  • The National Research Act of 1974
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Multiple Choice Questions
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