IRB Law Questions Complete Solution
IRB Law Questions
1. Which of the following studies is linked most directly to the establishment of the
... [Show More] 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.
2. The Belmont principle of beneficence requires that:
Potential benefits justify the risks of harm.
3. 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.
4. According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of:
Justice.
5. 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.
1. Which of the following are the three principles discussed in the Belmont Report?
Respect for Persons, Beneficence, Justice.
2. 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.
3. All of the following are true regarding the Belmont Report, EXCEPT:
The Belmont Report defines and delineates the differences between "Practice" and "Research".
The Belmont Report describes the concept of "Respect for Persons".
The Belmont Report indicates that it is necessary to rigorously avoid conflicts of interest.
The Belmont Report describes the need to carefully consider how research discoveries and risks will be fairly distributed in the society.
1. 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.
2. 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
3. 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
4. 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.
5. IRB continuing review of an approved protocol must:
Occur at least annually.
1. 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.
2. 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.
3. 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.
4. 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.
5. As part of the consent process, the federal regulations require researchers to:
Provide potential subjects with information at the appropriate reading comprehension level.
1. Data are made anonymous by
Destroying all identifiers connected to the data.
2. 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.
3. 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.
4. 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
5. 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 faculty member makes identifiable data about sexual behavior available to graduate students, although the subjects were assured that the data would be de-identified
1. 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?
Students taking one of his courses
2. 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?
The patients are institutionalized.
3. 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?
Potential undue influence or coercion of subjects
4. 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:
Undue influence on the subjects
1. 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
2. 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
3. A financial conflict of interest could involve:
Receiving stock in a company funding your research.
4. According to the DHHS 2011 updated of the PHS federal regulations, the threshold amount for reporting a significant financial interest (investigator and his/her spouse and dependents) is:
Greater than $5,000 of ownership in any single public entity/public company.
5. A conflict of interest implies:
The potential for bias.
6. 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. [Show Less]
