Human Subject & Data Only Researchers & Staff, IRB Members & Staff - Basic Course
An example of an individual financial COI is:
A researcher's spouse holds equity in a publicly traded pharmaceutical company that is also the sponsor of the researcher's study
Informed consent is considered an application of which Belmont principle?
Respect for Persons
Which of the following are the three principles discussed in the Belmont Report?
Respect for Persons, Beneficence, Justice
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
If you're unsure about the particulars of HIPAA research requirements at your organization or have questions, you can usually consult with:
An organizational IRB or Privacy Board, privacy official ("Privacy Officer"), or security official ("Security Officer"), depending on the issue.
The FDA regulations governing disclosure of individual COIs require:
Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies
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
HIPAA protects a category of information known as protected health information (PHI). PHI covered under HIPAA includes:
Identifiable health information that is created or held by covered entities and their business associates.
What are some considerations for a U.S. researcher conducting a study in a non-U.S. setting when obtaining informed consent from subjects?
In addition to the consent of the research subjects, are there other individuals or groups whose permission must be sought?
Which is true of inducements in research?
Inducements constitute an "undue influence" if they alter a potential subject's decision-making processes, such that they do not appropriately weigh the risk-benefit relationship of the research.
Which of the following is considered a SBR data collection method?
Interviews
A professor at Big State University proposes to study attitudes about obesity in Chile by giving subjects in Chile surveys to complete. Which is a question that the Big State University IRB should ask the researcher in order to determine if this study should be reviewed by a local Chilean IRB or ethics committee, as well as the Big State University IRB?
Will the researchers have collaborators at the research site abroad?
When an IRB is reviewing a research study and they are considering if a potential subject population is vulnerable, they should consider:
Is there a power differential between researchers and subjects?
A researcher calls you stating that he plans to submit a proposal to the NIH for a human subjects research study. He wants to know at what point he and his study team must submit COI disclosures to comply with the PHS regulation.
No later than the time of proposal submission
If the research is subject to Subpart D, which of the following research activities with children would qualify for an exemption under Category 2 (research that includes educational tests, surveys, interviews, observation)?
Research about aptitude testing
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?
PHS Tuskegee Study
If research in a private school is directly funded by the Department of Education, then:
PPRA applies.
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:
Persons with diminished autonomy are entitled to protection.
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?
Physical control, coercion, undue influence, and manipulation
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.
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 subjects (therapists)
HIPAA includes in its definition of "research," activities related to:
Development of generalizable knowledge.
The NBAC looks at characteristics individuals might have that would prevent them from being able to provide voluntary informed consent. The traits may be thought of as falling into six broad areas: cognitive or communicative, institutional, deferential, medical, economic, and social. Prospective research subjects who are not able to comprehend information, deliberate, and make decisions about participation in a proposed research study have a:
Cognitive or communicative vulnerability
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 subjects 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
HIPAA protects a category of information known as protected health information (PHI). PHI covered under HIPAA includes:
Data that does not cross state lines when disclosed by the covered entity.
Which of the following brought increased public attention to the problems with the IRB system?
Death of Research Subject (Jesse Gelsinger)
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
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
The National Research Act of 1974
Established the National Commission.
In addition to the general provisions of the Common Rule (the federal regulations for protecting research subjects), the following regulations also govern research in the public schools:
FERPA, PPRA, and Subpart D of the federal regulations
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 form is that it may not 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.
According to the Belmont Report, the requirement that the benefits and burdens of the research are equitably distributed, expresses the principle of:
Justice
An example cited in the Belmont Report (The National Commission 1979) stated that "During the 19th and early 20th centuries the burdens of serving as research subjects fell largely upon poor ward patients, while the benefits of improved medical care flowed primarily to private patients." This is an example of a violation of which Belmont principle?
Justice
The age of majority in international research is determined by the
Laws, customs, and norms in the area in which the research will be conducted.
Which of the following most accurately describes the risks associated with SBR?
Less predictable, more variable, and less treatable than physical harms
A researcher proposes a study and wants to recruit subjects from health care clinics in Jamaica. The survey will be conducted by the U.S. researchers at the clinic. The nurses at the clinic will inform prospective subjects about the availability of the research, but will not consent the subjects nor perform any research procedures (even screening procedures). Are the nurses engaged in the research according to federal regulations?
No, they are not engaged because they are only informing the subjects and not consenting or performing any research procedures, or receiving or sharing any private, identifiable information.
Which of the following activities constitutes engagement in research?
Obtaining informed consent and conducting research interviews.
IRB continuing review of a greater than minimal risk approved protocol that is currently enrolling subjects must:
Occur at least annually.
The use of prisoners in research is a concern under the Belmont principle of Justice because:
Prisoners may not be used to conduct research that only benefits the larger society
The purpose of the Family Educational Rights and Privacy Act (FERPA) is to:
Provide parents certain rights over their children's educational records.
The COI management plan aims to:
Provide procedures or extras steps to be taken to minimize the risk of bias when a COI is disclosed
Which of the following was the result of the Beecher article?
Realization that ethical abuses are not limited to the Nazi regime
An elderly gentleman, whose wife is his legally authorized representative (LAR) since his strokes several years ago, was recently diagnosed with lung cancer. He is eligible for a clinical trial using a new investigational drug that aims to treat lung cancer. He is able to express interest, shows a basic understanding of the nature of the trial, and gives his assent to participation. The subject's wife 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, she can sign the informed consent and fax it back.
In considering NBAC's analytic approach, an otherwise competent person who is acutely ill might be considered at especially high risk of harm for:
Situational cognitive vulnerability
Which federal regulation or law governs how researchers can obtain data about subjects' disciplinary status in school from academic records?
The Family Educational Rights and Privacy Act.
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.
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 LAR and no alternative method or recognized therapy is available. Under the FDA regulations for using test articles, which of the following describes the best course of action for the investigator:
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.
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 peer review process can create conflicts of interest because the choice of who reviews a potentially publishable project may show:
There may be bias by the peer reviewer as to the area of research
A HIPAA authorization has which of the following characteristics:
Uses "plain language" that the data subject can understand, similar to the requirement for an informed consent document.
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.Result
