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Certification for IRB Professionals (CIP) Exam, Exams of Business Statistics

Certification for IRB Professionals (CIP) Exam

Typology: Exams

2022/2023

Available from 10/12/2023

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Certification for IRB Professionals (CIP) Exam
According to the Belmont Report, respect for persons usually
demands that subjects... - Correct answer enter into research
voluntarily & with adequate information
According to the Belmont Report, the moral requirement that
there be fair outcomes in the selection of research subjects,
expresses the principle of: - Correct answer Justice
A poorly designed protocol is considered unethical because... -
Correct answer research subjects may be put at risk or
inconvenienced for insufficient reason
When should an IRB suspend or terminate approval of research?
- Correct answer When it is not being conducted in accordance
with the IRB's requirements
A quorum for a convened IRB meeting requires the presence of...
- Correct answer a nonscientific member
What is required in research involving no more than minimal risk
with children? - Correct answer Adequate provisions are made for
assent of the child and permission of parent or guardian
Federal regulations require each IRB to have written procedures
for... - Correct answer initial & continuing review of research and
for reporting its findings and actions to the investigator and the
institution
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Certification for IRB Professionals (CIP) Exam

According to the Belmont Report, respect for persons usually demands that subjects... - Correct answer enter into research voluntarily & with adequate information According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of: - Correct answer Justice A poorly designed protocol is considered unethical because... - Correct answer research subjects may be put at risk or inconvenienced for insufficient reason When should an IRB suspend or terminate approval of research?

  • Correct answer When it is not being conducted in accordance with the IRB's requirements A quorum for a convened IRB meeting requires the presence of...
  • Correct answer a nonscientific member What is required in research involving no more than minimal risk with children? - Correct answer Adequate provisions are made for assent of the child and permission of parent or guardian Federal regulations require each IRB to have written procedures for... - Correct answer initial & continuing review of research and for reporting its findings and actions to the investigator and the institution

What are the 3 ethical principles discussed in the Belmont Report? - Correct answer Respect for Persons, Justice, & Beneficence An example of how the Principle of Beneficence can be applied to a study employing human subjects? - Correct answer Determining that the study has a maximization of benefits & a minimization of risks. The researcher's failure to protect research subjects from deductive disclosure is the primary ethical violation of which study? - Correct answer Harvard "Tastes, Ties, and Time (T3)" study (2006-2009)" What is an example of how the principle of beneficence is applied to a study involving human subjects? - Correct answer Ensuring that risks are reasonable in relationship to anticipated benefits 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: - Correct answer Respect for Persons Which study 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? - Correct answer "The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male" The Belmont Principle of beneficence requires that... - Correct answer potential benefits justify the risks of harm 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? - Correct answer Report the

exculpatory language? - Correct answer "Taking part in the research is voluntary, but we choose you as a participant, you waive the right to legal redress for any research-related injuries" 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: - Correct answer 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. A waiver of the requirement for documentation of informed consent may be granted when: - Correct answer The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality. As part of the consent process, the federal regulations require researchers to: - Correct answer Provide potential subjects with information at the appropriate reading comprehension level. Data are made anonymous by... - Correct answer Destroying all identifiers connected to the data. 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? - Correct answer There was neither a violation of privacy nor a breach of confidentiality.

Which of the following constitutes both a breach of 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)? - Correct answer 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. The Right of Subject Privacy - Correct answer The right of the individuals to be protected against intrusion into their personal lives or affairs The Right of Subject Confidentiality - Correct answer Refers to a condition in which the researcher knows the identity of a research subject, but takes steps to protect that identity from being discovered by others. 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? - Correct answer Securing a Certificate of Confidentiality When a focus group deals with a potentially sensitive topic, which of the following statements about providing confidentiality to focus group participants is correct? - Correct answer Confidentiality is not guaranteed: The researcher cannot control what participants repeat about others outside the group. longitudinal study - Correct answer a study that observes the same participants on many occasions over a long period of time

A financial conflict of interest could involve - Correct answer Receiving stock in a company funding your research. Conflict of Interest - Correct answer A situation in which financial or other personal considerations have the potential to compromise or bias professional judgment and objectivity is an example of: Identify the following groups that are protected in the federal regulations (45 CFR 46), specifically in Subparts B, C and D with additional protections: - Correct answer Subpart B: Pregnant women, human fetuses and neonates; Subpart C: Prisoners; and Subpart D: Children