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.
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.
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
Research investigators are responsible for retaining signed consent documents, IRB correspondence, and research records for at least three years after completion of the research. Because research records are the property of the institution, local institutional policy or sponsoring agency requirements may dictate these records are kept longer. The sponsor and the IRB office should be contacted to make sure that the minimum of three years meets their requirements.
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
The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulations. Expedited review procedures are appropriate only for protocols that present no greater than “minimal risk” to subjects and involve only procedures included in federally specified categories. Population considerations, such as healthy volunteers, are only relevant insofar as they affect the assessment of risk. The IRB may not conduct an expedited review for the convenience of either the IRB or a student researcher, if the protocol is otherwise not eligible.
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.
IRB continuing review of a greater than minimal risk approved protocol that is currently enrolling subjects must:
Occur at least annually.
All amendments involving changes to IRB-approved protocols must be reviewed and approved in advance of implementation, unless changes must be put in place immediately to respond to an unexpected risk or problem arising during the course of a study.
Approved greater than minimal risk protocols must be reviewed at least annually, although IRBs may specify a shorter review period. It is the responsibility of the principal investigator to hold signed consent forms in confidentiality. Copies of these forms are not required by federal regulation to be reviewed by the IRB. Please note, however, that an institution’s local policy may require copies of signed consent forms as part of the IRB continuing review process.
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.
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
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
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.
IRB continuing review of an approved protocol must:
Occur at least annually.
Which of the following are the three principles discussed in the Belmont Report?
Respect for Persons, Beneficence, Justice.
Issued in 1974, 45 CFR 46 raised to regulatory status:
US Public Health Service Policy
Which of the following was the result of the Beecher article?
The use of prisoners in research is a concern under the Belmont principle of Justice because:Prisoners may be used to conduct research that only benefits the larger society
Which of the following brought increased public attention to the problems with the IRB system?
Death of Jesse Gelsinger
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.
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
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
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.
IRB continuing review of an approved protocol must
Occur at least annually.
A 46-year-old man is currently enrolled in a Phase 2 study of a drug for severe diabetic neuropathy. While the study is on going, a new drug becomes commercially available that may have equal or greater benefit to the subject. The investigator should do which of the following?
Give the subject comprehensive information about the new drug, including its side effects. Discuss the pros and cons of both the investigational drug and the commercially available drug and then allow the subject to decide whether to withdraw from the research to take the new drug.
A general requirement for the 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?
I waive any possibility of compensation for injuries that I may receive as a result of participation in this research
A man in his early 50s, who was recently diagnosed with lung cancer, is screened for a clinical trial using a new investigational drug. The investigator has carefully explained all of the required information about the study to the subject and the subject’s daughter. The subject demonstrates his understanding and willingness to participate, but is not able to sign or mark the informed consent document due to a recent accident where he burned both hands. The subject’s wife is his legally authorized representative, but she is out of town on a business trip. Which of the following is the most appropriate action to take for the investigator?
Send a copy of the informed consent via facsimile to the subject’s wife. After she has had the opportunity to speak to the investigator and her husband, she can sign the informed consent and fax it back
An investigator is confronted with a life-threatening situation that necessitates using a test article in a human subject who is unable to provide informed consent and there is no time to obtain consent from the individual’s legal representative and no alternative method or recognized therapy is available. Under the FDA regulations for using test articles, which of the following describes the best cou
The investigator and an independent physician agree that the situation necessitates the use of the test article. An exception or waiver for informed consent can be made under these circumstances. The IRB will be notified later.
The purpose of informed consent is
To provide a potential subject with appropriate information in an appropriate manner and allow that person to make an informed decision about participation in research.
A researcher is conducting a written survey about people’s attitudes toward walking as an exercise option at the local shopping mall that supports a walking program. The survey is anonymous (without codes, names or other information) and volunteers may complete the survey and place it in a box at the shopping mall exits. Which of the following is the most important issue that the researcher addressed in planning the research?
Confidentiality of the individual subject’s responses
A researcher wants to invite therapists to participate in small focus groups to discuss their perceptions regarding “troubled” adolescent girls and the relationships they have with their parents. Specific clients of the therapists will not be discussed. Which of the following will be the most important issue for the researcher to consider when planning the research?
Breach of confidentiality from the focus group participants
Which of the following most accurately describes the risks associated with SBR?
Less predictable, more variable and less treatable than physical harms
Which of the following is not considered an SBR data collections method?
hearing/audiological screenings
A researcher wants to conduct a secondary analysis using CDC database that was collected by the agency solely for surveillance purposes. The researcher did not participate in the initial collection of the data. The database is publicly available. The database does not include any identifiers. The IRB makes a determination that the individuals whose records will be reviewed do not meet the federal definition of human subjects. Which of the following considerations was relevant to the IRB’s determination that this activity does not constitute research with human subjects?
The researcher will not be interacting/intervening with subjects and the data has no identifiers.
An investigator obtains consent from subjects to review their medical records and HIV status. He plans to go back to the medical record, so the HIV status information is stored along with patient identifiers in a database that he keeps on his laptop computer. His laptop is stolen. This incident constitutes:
A breach of confidentiality.
Under which of the following conditions is it appropriate to re-contact the individuals who provided biological specimens?
Original signed consent documents include provisions for recontacting subjects
When conducting research that involves collecting biological specimens for genetic testing, which of the following issues is the most important for the IRB to consider?
Effects of findings on other family members
A faculty member wants to measure the effectiveness of a new psychological assessment instrument. 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
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.
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
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
Which of the following is included in the Nuremberg Code:
Voluntary consent
Informed consent is considered an application of which Belmont principle?
Respect for persons
The National Research Act of 1974?
Established the National Commission
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