CIP Vulnerable Populations & Special Protections Flashcards
6 cards from real CIP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 CIP Vulnerable Populations & Special Protections flashcards as text
Which subpart of 45 CFR 46 provides additional protections for pregnant women, human fetuses, and neonates?
Answer: Subpart B
45 CFR 46 Subpart B specifically addresses additional protections for pregnant women, human fetuses, and neonates involved in research.
Under 45 CFR 46 Subpart D, research involving children may be approved if it presents greater than minimal risk with no direct benefit only when:
Answer: The risk represents only a minor increase over minimal risk and the intervention is commensurate with those in the child's actual situation
46.406 permits approval of research with greater-than-minimal risk and no direct benefit only when risk is a minor increment above minimal and the procedures are similar to those in the child's life experience.
What is required to enroll a child in research under 45 CFR 46 Subpart D when the research poses greater than minimal risk with direct benefit?
Answer: Permission of at least one parent or guardian and the child's assent
For research with prospect of direct benefit under 46.405, permission of at least one parent and the child's assent (where appropriate) are required.
Which federal subpart provides additional protections for prisoners as research subjects?
Answer: 45 CFR 46 Subpart C
Subpart C of 45 CFR 46 provides special protections for prisoners, requiring that the majority of subjects in the study be non-prisoners and restricting permissible research categories.
When enrolling cognitively impaired adults in research, the IRB must ensure:
Answer: Consent or assent is obtained from the subject to the extent possible, along with LAR permission when required by the protocol risk level
IRBs must evaluate whether subjects with cognitive impairment can provide meaningful assent and whether LAR consent is required based on the level of risk.
Under Subpart C, which of the following is a permissible category of research involving prisoners?
Answer: Research on conditions particularly affecting prisoners as a class, such as the effects of incarceration
45 CFR 46.306 permits research on conditions particularly affecting prisoners as a class, provided additional safeguards and OHRP concurrence requirements are met.