CIP CIP Vulnerable Populations & Special Protections 1 — Questions and Answers
Question 1: Which subpart of 45 CFR 46 provides additional protections for pregnant women, human fetuses, and neonates?
- Subpart B (Correct answer)
- Subpart A
- Subpart C
- Subpart D
Correct answer: Subpart B
45 CFR 46 Subpart B specifically addresses additional protections for pregnant women, human fetuses, and neonates involved in research.
Question 2: 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:
- The risk represents only a minor increase over minimal risk and the intervention is commensurate with those in the child's actual situation (Correct answer)
- Any risk level is acceptable if parents consent
- The IRB chair approves the risk level
- The sponsor certifies the risk is justified
Correct 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.
Question 3: 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?
- Permission of at least one parent or guardian and the child's assent (Correct answer)
- Permission of both parents and a court order
- The child's assent alone is sufficient if they are over 12
- Federal sponsor approval and both parents' permission
Correct 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.
Question 4: Which federal subpart provides additional protections for prisoners as research subjects?
- 45 CFR 46 Subpart C (Correct answer)
- 45 CFR 46 Subpart B
- 45 CFR 46 Subpart D
- 21 CFR 50 Subpart B
Correct 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.
Question 5: When enrolling cognitively impaired adults in research, the IRB must ensure:
- Consent or assent is obtained from the subject to the extent possible, along with LAR permission when required by the protocol risk level (Correct answer)
- The subject's diagnosis is the primary eligibility criterion
- Consent from any family member is always sufficient
- A court has formally declared the subject incompetent
Correct 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.
Question 6: Under Subpart C, which of the following is a permissible category of research involving prisoners?
- Research on conditions particularly affecting prisoners as a class, such as the effects of incarceration (Correct answer)
- Research designed solely to benefit the institution's security operations
- Research that would not be conducted outside the prison setting for economic reasons
- Any research approved by the warden and a majority of prisoners
Correct 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.
CIP CIP Vulnerable Populations & Special Protections 1
Which subpart of 45 CFR 46 provides additional protections for pregnant women, human fetuses, and neonates?