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.
D. The therapist creates her clients’ records; therefore, she does not need parents’ permission to use the information for research purposes.

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.

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?
A. In the event of any distress you may have related to this research, you will be given access to appropriate resources.
B. The researcher may stop you from taking part in this research without your consent if you experience side effects that make your emotional condition worse. If you become too emotionally distressed during the research, you may have to drop out.
C. Your participation in this research is voluntary. If you choose not to participate, or change your mind later, your decision will not affect your relationship with the researcher or your right to other services that you may be eligible for.
D. 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.

D. 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 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. A study in which subjects were told that they performed in the third quartile on an anagram task when in reality students were randomly assigned scores that were not related to their actual performance.
B. A study in which researchers told students that they would be given a quiz after reading some study materials when the researchers did not intend to use a quiz, but were attempting to focus subjects’ attention on the material.
C. A study involving decision-making games in which subjects were led to believe that they were interacting with another student in another room, but were actually interacting with a computer programmed to provide consistent responses to all subjects.
D. 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.

D. 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:
A. The subjects are literate in their own language; however, they do not read, write, or speak English
B. The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality.
C. Potential subjects might find some of the research questions embarrassing, personal, or intrusive
D. The investigator has no convenient place to store signed consent forms separate from the research data

B. 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:
A. Provide potential subjects with information at the appropriate reading comprehension level.
B. Provide a list of the IRB members who reviewed the protocol.
C. Recommend that potential subjects discuss their decision to participate with family members.
D. Describe penalties that may be imposed for non-participation.

A. Provide potential subjects with information at the appropriate reading comprehension level.

Data are made anonymous by
A. Keeping the key linking names to responses in a secure location.
B. Reporting data in aggregate form in publications resulting from the research.
C. Requiring all members of the research team to sign confidentiality agreements.
D. Destroying all identifiers connected to the data.

D. Destroying all identifiers connected to the data.

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?
A. Waiving documentation of consent.
B. Using pseudonyms in research reports.
C. Using data encryption for stored files.
D. Securing a Certificate of Confidentiality.

D. 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?
A. Using pseudonyms in reports removes the concern about any confidences shared in the group.
B. If group participants sign confidentiality agreements, the researcher can guarantee confidentiality.
C. If group members know each other confidentiality is not an issue.
D. The researcher cannot control what participants repeat about others outside the group.

D. The researcher cannot control what participants repeat about others outside the group.

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?
A. Confidentiality of the data has been breached
B. There was both a violation of privacy and a breach of confidentiality.
C. The subjects’ privacy has been violated.
D. There was neither a violation of privacy nor a breach of confidentiality

D. There was neither a violation of privacy nor a breach of confidentiality

Which of the following constitutes both a breach of a 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. A researcher, who is a guest, audio-records conversations at a series of private dinner parties to assess gender roles, without informing participants.
B. In order to eliminate the effect of observation on behavior, a researcher attends a support group and records interactions without informing the attendees.
C. A researcher asks cocaine users to provide names and contact information of other cocaine users who might qualify for a study.
D. 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.

D. 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.

A faculty member wants to measure the effectiveness of a new psychological assessment instrument before including it in his new textbook. He plans to conduct a pilot test by administering both the new instrument and an established instrument and then compare the results. Which of the following populations might be most vulnerable to undue influence to participate in his research?
A. Members of his community organization
B. Senior faculty in his department
C. Members of his professional society
D. Students taking one of his courses

D. Students taking one of his courses

An investigator is recruiting subjects for a study of a new antidepressant drug. The investigator has targeted a population of patients who might clearly benefit, but who are also institutionalized for a variety of psychiatric conditions. The patients are in a controlled environment and it is believed there would be little problem recruiting subjects for the study. Which of the following issues of vulnerability should be of most concern to the IRB?
A. The patients have clinical depression, which is a difficult disease to treat.
B. The patients are institutionalized.
C. The patients are probably illiterate.
D. The patients may have experience participating in research.

B. The patients are institutionalized.

An investigator planning to study behavioral changes during alcohol intoxication will pay subjects $600 for 6 hours of testing that includes drinking a moderate level of alcohol and completing several written questionnaires. He plans to recruit college students taking his courses, as well as economically disadvantaged and homeless people. Which of the following is the most important for the investigator to address before submitting the protocol to the IRB?
A. Potential undue influence or coercion of subjects
B. Method of payment to subjects
C. Forms of advertising for subject recruitment
D. Literacy of homeless subjects

A. Potential undue influence or coercion of subjects

A group of elderly men, whose government disability benefits are the sole source of income, is approached regarding an experimental research study. The study involves using different therapeutic interventions in men with colon cancer. The study involves more than minimal risk, but offers substantial financial incentives that are equal to two months of disability benefits. The IRB will be most concerned about the possibility of:
A. Conflict of interest
B. Inadequacy of research design
C. Inaccuracy of data
D. Undue influence on the subjects

D. Undue influence on the subjects

A situation in which financial or other personal considerations have the potential to compromise or bias professional judgment and objectivity is an example of:
A. Fraud
B. Research Misconduct
C. Conflict of Interest
D. Malfeasance

C. Conflict of Interest

A conflict of interest implies:
A. The elimination of bias.
B. An awareness of bias.
C. The actual involvement of bias.
D. The potential for bias.

D. The potential for bias.

The 1998 FDA regulations for requiring disclosure of significant financial interest reflect which threshold:
A. Any equity interest in a publicly held company that exceeds $50,000
B. Any equity interest in a publicly held company that exceeds $5,000
C. Any equity interest in a publicly held company that exceeds $15,000
D. Any equity interest in a publicly held company that exceeds $30,000

B. Any equity interest in a publicly held company that exceeds $5,000

The most important ethical concerns related to conflicts of interest in research are:
A. Establishing open dialog with sponsors and security of study records
B. Maintaining a supply of volunteers for research studies and their active involvement in research
C. Ensuring the objectivity of research and the protection of human subjects
D. Protecting proprietary information and fidelity to contracts with sponsors

C. 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:
A. Institutional Review Boards
B. Designated institutional officials
C. Funding agency or sponsor
D. Subjects/participants

B. Designated institutional officials