IRB - Law
Which of the following are the three principles discussed in the Belmont Report?
A. IRB review, Federal regulations, Declaration of Helsinki.
B. Informed Consent, Institutional Assurance, Researcher responsibility.
C. Privacy, Confidentiality, Equitable selection of subjects.
D. Respect for Persons, Beneficence, Justice.
D. 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?
A. Providing detailed information about the study and obtaining the subject's consent to participate.
B. Determining that the study has a maximization of benefits and a minimization of risks.
C. Ensuring that the selection of subjects includes people from all segments of the population.
D. Ensuring that persons with diminished autonomy are protected.
B. 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:
A. The Belmont Report describes the need to carefully consider how research discoveries and risks will
be fairly distributed in the society.
B. The Belmont Report describes the concept of "Respect for Persons".
C. The Belmont Report defines and delineates the differences between "Practice" and "Research".
D. The Belmont Report indicates that it is necessary to rigorously avoid conflicts
D. The Belmont Report indicates that it is necessary to rigorously avoid conflicts
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?
A. The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male.
B. Stanford Prison Experiment (Zimbardo).
C. The Harvard T3 study.
D. Tearoom Trade Study (Humphreys).
A. The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male.
The Belmont principle of beneficence requires that:
A. Subjects derive individual benefit from study participation.
B. Potential benefits justify the risks of harm.
,C. The study makes a significant contribution to generalizable knowledge.
D. Risks are managed so that they are no more than minimal.
B. Potential benefits justify the risks of harm.
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:
A. Respect for persons.
B. Justice.
C. Beneficence.
A. Respect for persons.
According to the Belmont Report, the moral requirement that there be fair outcomes in the selection
of research subjects, expresses the principle of:
A. Beneficence.
B. Respect for persons.
C. Justice.
C. Justice.
Which of the following is an example of how the principle of beneficence is applied to a study
involving human subjects?
A. Ensuring that subjects understand that participation is voluntary.
B. Ensuring that the selection of subjects is fair.
C. Providing detailed information about the study to potential subjects.
D. Ensuring that risks are reasonable in relationship to anticipated benefits.
D. Ensuring that risks are reasonable in relationship to anticipated benefits.
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?
A. Do not report the adverse drug experience to the IRB since it is a common adverse experience.
B. Report the adverse drug experience to the IRB only if there are several other occurrences.
C. Report the adverse drug experience as part of the continuing review report.
D. 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.
D. 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?
A. Until the study is closed
, B. Until data analysis is complete
C. For a minimum of three years after completion of the study
D. As long as the investigator is at that institution
C. 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?
A. The study involves no more than minimal risk and meets one of the allowable categories of
expedited review specified in federal regulations
B. The study is required for a student research project
C. The study does not require informed consent or survey instruments.
D. The study includes only research subjects that are healthy volunteers.
A. 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:
A. The investigator keeps careful records of all changes and includes them in the final report.
B. They only involve changes to the consent form.
C. They are eligible for review using expedited procedures.
D. The changes must be immediately implemented for the health and well being of the subject.
D. The changes must be immediately implemented for the health and well being of the subject.
IRB continuing review of an approved protocol must:
A. Be conducted by a convened IRB.
B. Include copies of all signed consent forms.
C. Occur only when the level of risk changes.
D. Occur at least annually.
D. 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?
A. The superintendent of the school system can give permission for children to be in the study;
therefore, the therapist doesn't have to ask the parents for permission.
B. 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.
C. If it is the best interests of the community that the children participate in the study, parental
permission is optional.
Which of the following are the three principles discussed in the Belmont Report?
A. IRB review, Federal regulations, Declaration of Helsinki.
B. Informed Consent, Institutional Assurance, Researcher responsibility.
C. Privacy, Confidentiality, Equitable selection of subjects.
D. Respect for Persons, Beneficence, Justice.
D. 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?
A. Providing detailed information about the study and obtaining the subject's consent to participate.
B. Determining that the study has a maximization of benefits and a minimization of risks.
C. Ensuring that the selection of subjects includes people from all segments of the population.
D. Ensuring that persons with diminished autonomy are protected.
B. 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:
A. The Belmont Report describes the need to carefully consider how research discoveries and risks will
be fairly distributed in the society.
B. The Belmont Report describes the concept of "Respect for Persons".
C. The Belmont Report defines and delineates the differences between "Practice" and "Research".
D. The Belmont Report indicates that it is necessary to rigorously avoid conflicts
D. The Belmont Report indicates that it is necessary to rigorously avoid conflicts
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?
A. The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male.
B. Stanford Prison Experiment (Zimbardo).
C. The Harvard T3 study.
D. Tearoom Trade Study (Humphreys).
A. The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male.
The Belmont principle of beneficence requires that:
A. Subjects derive individual benefit from study participation.
B. Potential benefits justify the risks of harm.
,C. The study makes a significant contribution to generalizable knowledge.
D. Risks are managed so that they are no more than minimal.
B. Potential benefits justify the risks of harm.
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:
A. Respect for persons.
B. Justice.
C. Beneficence.
A. Respect for persons.
According to the Belmont Report, the moral requirement that there be fair outcomes in the selection
of research subjects, expresses the principle of:
A. Beneficence.
B. Respect for persons.
C. Justice.
C. Justice.
Which of the following is an example of how the principle of beneficence is applied to a study
involving human subjects?
A. Ensuring that subjects understand that participation is voluntary.
B. Ensuring that the selection of subjects is fair.
C. Providing detailed information about the study to potential subjects.
D. Ensuring that risks are reasonable in relationship to anticipated benefits.
D. Ensuring that risks are reasonable in relationship to anticipated benefits.
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?
A. Do not report the adverse drug experience to the IRB since it is a common adverse experience.
B. Report the adverse drug experience to the IRB only if there are several other occurrences.
C. Report the adverse drug experience as part of the continuing review report.
D. 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.
D. 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?
A. Until the study is closed
, B. Until data analysis is complete
C. For a minimum of three years after completion of the study
D. As long as the investigator is at that institution
C. 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?
A. The study involves no more than minimal risk and meets one of the allowable categories of
expedited review specified in federal regulations
B. The study is required for a student research project
C. The study does not require informed consent or survey instruments.
D. The study includes only research subjects that are healthy volunteers.
A. 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:
A. The investigator keeps careful records of all changes and includes them in the final report.
B. They only involve changes to the consent form.
C. They are eligible for review using expedited procedures.
D. The changes must be immediately implemented for the health and well being of the subject.
D. The changes must be immediately implemented for the health and well being of the subject.
IRB continuing review of an approved protocol must:
A. Be conducted by a convened IRB.
B. Include copies of all signed consent forms.
C. Occur only when the level of risk changes.
D. Occur at least annually.
D. 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?
A. The superintendent of the school system can give permission for children to be in the study;
therefore, the therapist doesn't have to ask the parents for permission.
B. 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.
C. If it is the best interests of the community that the children participate in the study, parental
permission is optional.
