The FDA regulations governing disclosure of individual COIs require:
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Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies Explanation: The FDA regulations governing disclosure of individual conflicts of interest require that individuals disclose any financial interests or relationships that could be reasonably seen as affecting their ability to impartially conduct FDA-regulated research. These interests include, but are not limited to, ownership of stock in a company, being a paid consultant for a company, or holding a patent for a product.
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The PHS regulations about financial conflict of interests require which party to disclose significant financial conflicts of interest?
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Researcher Explanation: All parties involved in Public Health Service (PHS) research are required to disclose any significant financial conflicts of interest. This includes investigators, institutions, and companies.
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What is the term for management controls that are built in to a research study (for example, independent data analysis)?
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Inherent controls Explanation: There is no one definitive answer to this question. However, one possible answer is that the term for management controls that are built in to a research study is quality control." Quality control is a process that is used to ensure that a research study is conducted in a manner that is consistent with the standards that have been established for that study. Quality control includes procedures and checks that are put in place in order to verify that the data that is collected is accurate and that the study is being conducted in a way that is ethical and reliable."
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A researcher's membership on an advisory board with an organization sponsoring research can create a COI because:
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It may be difficult for the researcher to appear neutral, as the researcher may have an interest in the research's success Explanation: The researcher may feel obligated to the organization to produce results that support the organization's goals, rather than results that are objective and unbiased. Additionally, the researcher may be given preferential treatment or access to resources by the organization, which could skew the results of the research in the organization's favor.
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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.
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No later than the time of proposal submission Explanation: The PHS regulation requires that COI disclosures must be submitted at the time of application for the human subjects research study.
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A researcher conducts a focus group to learn about attitudes towards hygiene and disease prevention. Two weeks after the focus group, the researcher learns one of the subjects had a heart attack at home and was hospitalized, but made a full recovery. Based on DHHS regulations, should the researcher report this event to the IRB?
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No, this does not need to be reported since it is unrelated to participation in the study. Explanation: The researcher should report this event to the IRB. The regulations require that any unanticipated problems that occur during the course of a study be reported to the IRB. This includes any serious adverse events that occur to participants.
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The procedures for reporting potential unanticipated problems involving risk to subjects or others to the IRB are:
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Determined by the institution in its written policies and procedures Explanation: The procedures for reporting potential unanticipated problems involving risk to subjects or others to the IRB are as follows:1. Any member of the research team may report a potential unanticipated problem involving risk to the IRB Chair.2. The IRB Chair will convene a meeting of the IRB to discuss the problem and determine whether it represents an unanticipated problem involving risk.3. If the IRB determines that the problem does represent an unanticipated problem involving risk, the IRB will take steps to protect the subjects and/or others, as appropriate. These steps may include, but are not limited to, modifying the protocol, suspending or terminating the study, or notifying the sponsor or regulatory authorities.4. The IRB will document its decision and the rationale for its decision in the minutes of the meeting at which the problem was discussed.
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Researchers must report potential unanticipated problems that involve risks to others directly to:
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Institutional Review Board (IRB) Explanation: The Institutional Review Board (IRB) is responsible for monitoring the welfare of human research subjects. Researchers must report any potential unanticipated problems that involve risks to others directly to the IRB.
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A researcher conducting behavioral research collects individually identifiable sensitive information about illicit drug use and other illegal behaviors by surveying college students. The data are stored on a laptop computer without encryption, and the laptop computer is stolen from the researcher's car on the way home from work. This is an unanticipated problem that must be reported because the incident was (a) unexpected (i.e., the researchers did not anticipate the theft); (b) related to participation in the research; and (c) placed the subjects at a greater risk of psychological and social harm from the breach in confidentiality of the study data than was previously known or recognized. According to OHRP, this unanticipated problem must be reported to the IRB in which timeframe?
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Promptly Explanation: The unanticipated problem must be reported to the IRB within 10 days of the occurrence.
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A researcher conducting behavioral research collects individually identifiable sensitive information about illicit drug use and other illegal behaviors by surveying college students. One of the subjects is in an automobile accident two weeks after participating in the research study. Is this an example of an unanticipated problem that requires reporting to the IRB?
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No, this does not need to be reported because it was assessed by the researcher as unrelated to the research study. Explanation: Yes, this is an example of an unanticipated problem that requires reporting to the IRB. The researcher should report the incident to the IRB as soon as possible, and should also investigate whether the subject's participation in the research study may have contributed to the accident.
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According to OHRP, a problem is an "unanticipated problem" when it meets which of the following criteria:
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Unexpected, related or possible related to the research, suggests the research puts subjects or others at greater risk Explanation:Yes, this is an example of an unanticipated problem that requires reporting to the IRB. The researcher should report the incident to the IRB as soon as possible, and should also investigate whether the subject's participation in the research study may have contributed to the accident.
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During an Institutional Review Board (IRB) meeting, any IRB member who may have a potential COI with a study under review should:
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Disclose their potential COI and may answer questions, but recuse themselves from voting Explanation: When an IRB member has a potential conflict of interest with a study under review, they should excuse themselves from the meeting and not participate in the review or discussion of that study.
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The peer review process can create conflicts of interest because the choice of who reviews a potentially publishable project may show:
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There may be bias by the peer reviewer as to the area of research Explanation: The peer review process can create conflicts of interest because the choice of who reviews a potentially publishable project may show favoritism or nepotism. The process may also be biased if the reviewers are friends or colleagues of the author.
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An example of an institutional COI is:
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An industry sponsor pays for the construction of a new research laboratory at the organization Explanation: An institutional conflict of interest (COI) is a situation in which a person or organization is involved in multiple interests, one of which could possibly corrupt the motivation or decision-making of the individual or organization.An example of an institutional COI would be if a university researcher was also on the board of a company that could benefit from the researcher's findings. In this case, the researcher's objectivity could be called into question, as they could be motivated to produce results that would benefit the company, rather than advance knowledge for the sake of knowledge itself.
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The COI management plan aims to:
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Provide procedures or extras steps to be taken to minimize the risk of bias when a COI is disclosed Explanation: The COI management plan aims to:-identify and assess the organization's exposure to potential conflicts of interest;-develop policies and procedures to prevent and resolve conflicts of interest;-monitor compliance with the policies and procedures; and- periodically review and update the policies and procedures.
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