SOCRA certification: Class Quizzes Week 1-5 – Flashcards
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The ICH is concerned with harmonization of technical requirements for registration of pharmaceutical products from what three regions?
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European Union, Japan and United States
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What organizations are represented in the ICH Steering Committee?
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Australia, Canada, the Nordic countries and the World Health Organization (WHO), European Union, Japan, and the United States
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What ethical standards are the ICH Documents based on?
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Declaration of Helsinki
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What is the status of ICH in U.S.?
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It is a guideline
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A primary purpose of the ICH is to: A. Develop mandatory worldwide regulations for drug development B. Require publication of negative trial results. C. Minimize the need for redundant research. D. Require FDA registration of worldwide clinical trials.
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C. Minimize the need for redundant research
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The ICH GCP Guidelines: A. Replace FDA regulations for internationally conducted studies of drugs that will be marketed in the U.S. B. Require certification of clinical research sites and investigators. C. Guarantee that a submission in any ICH region will be approved for marketing. D. Set standards for the design, conduct, monitoring and reporting of clinical research.
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D. Set standards for the design, conduct, monitoring and reporting of clinical research.
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What are the three principles discussed in the Belmont Report?
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Justice, Beneficence, and Respect for Persons
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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. Insuring that the selection of subjects includes people from all segments of the population. C. Determining that the study has maximized benefits and minimized risks. D. Ensuring that confidentiality is maintained.
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C. Determining that the study has maximized benefits and minimized risks.
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Which of the following best describes the principle of informed consent as described in the Belmont Report? A. Voluntariness, risk/benefit assessment, selection of subjects. B. Comprehension, conflicts of interest, risk/benefit ratio. C. Risk/benefit assessment, justification of research, comprehension. D. Information, comprehension, voluntariness.
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D. Information, Comprehension, voluntariness.
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What important ethical principles were the result of experimentation in concentration camps during WWII?
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Nuremberg Code
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What pivotal study triggered the development of US research regulation and the Belmont Report?
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Syphilis Study at Tuskagee
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What organization developed the Declaration of Helsinki? A. World Health Organization B. World Medical Association C. US Congress D. FDA
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B. World Medical Association
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Who is the Declaration of Helsinki mainly meant to address? A. Physicians B. Nurses C. Study Coordinators D. Research Technicians.
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A. Physicians
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Who published a manuscript in the New England Journal of Medicine presenting evidence that unethical studies were wide spread and represented a systemic problem in medical research? A. Peter Buxton B. Henry Beecher C. Stanley Milgram D. Laud Humphreys
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B. Henry Beecher
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What does part A of the Belmont Report Cover? A. Boundaries between practice and research B. Respect for persons. C. Beneficence. D. Justice.
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A. Boundaries between practice and research
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Ensuring that a subject is treated as an autonomous agent is a reflection of what ethical principle?
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Respect for Persons
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Selecting subjects based on reasons directly related to the problem being studied is a reflection of what ethical principal? A. Boundaries between practice and research B. Respect for persons C. Beneficence D. Justice
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D. Justice
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According to DHHS and FDA regulations, who can conduct expedited review?
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The IRB chair, other IRB members designated by the chair, or a sub-committee of the IRB
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The IRB may invite non-members with expertise in special areas for assistance. True or False
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True
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In accordance with DHHS and FDA regulatory requirements, expedited review can be conducted on:
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A study involving no more than minimal risk and is on the DHHS and FDA specified list of categories eligible for expedited review
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Private information must be individually identifiable in order to constitute research involving human subjects. True or False
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True
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The following statement supports which one of the criteria for IRB approval of research? Blood for research lab tests will be drawn at the same time as for clinically indicated labs so that an extra needle stick is not necessary.
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Risks to subjects are minimized.
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According to regulation an IRB must ensure that it does not consist of entirely one
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gender or profession
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A systemic investigation including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge is the regulatory definition of A. Clinical Trial B. Investigation C. Research D. All of the above
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All of the above
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Research may receive approval if there is a minority of the IRB members present at the convened meeting. True or False?
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False
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Which 45 CFR 46 subpart did the FDA adopt? A. B B. C C. D D. All of the above
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All of the above
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OHRP is an oversight body primarily concerned with:
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Protection of human research subjects
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What type of research is covered by the regulations at 21 CFR 50?
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FDA regulated research
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This regulation is also referred to as the Common Rule
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45 CFR 46 Subpart A
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When a clinician uses a test article for Emergency Use is prior IRB approval required?
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No
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Any experiment that involves a test article and one or more human subjects is the regulatory definition of
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A clinical investigation
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What member of the IRB must be present for an IRB meeting to be conducted?
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The non-scientist
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Informed consent may be completely waived in emergency medicine research when: A. The research involves an investigational intervention under FDA special regulation at 21 CFR 50.24 B. Any unconscious patient requires emergency medical care C. The research is to be conducted with minors, pregnant women, or prisoners D. The research does not have the personnel available to obtain consent
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A.
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Which of the following federal agencies has issued guidance stating that research subjects should be informed that the agency may review the subjects' individual medical records. A. NIH B. FBI C. FDA D. OHRP
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C. FDA
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According to regulations, "exculpatory language": a. includes only language that would release the institution/investigator from liability for wrongful acts. b. describes the reimbursement that the investigator can receive from the study sponsor c. includes any language through which the subject is made to waive, or appear to waive, any of the subject's legal rights d. describes the investigator's right to penalize the subject for poor compliance with the protocol
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C. Includes any language through which the subject is made to waive, or appear to waive, any of the subjects legal rights.
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The signature of a witness on the standard (long form) consent document: A. Is required by federal regulations for research participation B. Indicates that the witness was present during the entire consent conference C. Is not required by federal regulations when the (standard long form) consent document is signed by the subject or the subject's legally authorized representative. D. Indicates that the subject's LAR was not available.
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C. Is not required by federal regulations when the (standard long form) consent document is signed by the subject or the subject's legally authorized representative.
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What situation is most likely to qualify for waiver of informed consent? A. Research to evaluate prospectively a new material for preparing dental cavities B. Research that tests donated blood for evidence of illegal drug use C. Research that involves a retrospective review of data from the medical record to evaluate outcome following elective pregnancy termination (abortion) D. Research that involves a retrospective review of data from the medical record to evaluate outcome following hip replacement surgery.
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D
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Regarding subject signature on consent forms, which is true about dates? A. Both FDA and ICH require B. Only FDA requires C. Neither FDA nor ICH require D. Only ICH requires
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A
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According to ICH, an impartial witness should be present during the entire informed consent discussion when subjects or legally authorized representatives are unable to read. True or False?
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True
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In terms of explaining the probability of assignment to trial arms in consent forms, which is true? A. Only the FDA recommends it B. Both FDA and ICH require it C. ICH notes that it should be included
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C.
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If a short-form consent is used to obtain consent from a subject who does not speak English, what form would the witness sign? A. The English Version of the long consent form. B. The translated version of the short form C. Neither, only the subject and the person obtaining consent sign. D. Both A and B
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D. Both A and B.
