Lesson 15 · IRB and HRPP Administration: From Coordinator to CIP

15. Subparts B and C: Pregnant Women, Fetuses, Neonates, and Prisoners

55 min

After this lesson you can

  • Apply the conditions for research involving pregnant women or fetuses in 45 CFR 46.204
  • Distinguish research with viable, nonviable, and uncertain-viability neonates under 46.205
  • State the prisoner definition, the IRB composition rule, and the additional duties in Subpart C
  • Apply the four permissible categories of prisoner research in 46.306 and the OHRP certification requirement
  • Explain what happens when an enrolled subject becomes a prisoner

Video coming soon

Scheduled for release on October 1, 2026.

Subparts B and C: Pregnant Women, Fetuses, Neonates, Prisoners covers the additional protections in 45 CFR 46 exactly as the CIP exam tests them. You will learn the ten conditions for pregnancy research, the three neonate categories, the seven prisoner findings, the four permitted categories, and OHRP certification.

5 Key Facts from This Lesson

  1. The father's consent is required only when the direct benefit is solely to the fetus, and even then it is excused if he is unavailable, incompetent, temporarily incapacitated, or the pregnancy resulted from rape or incest.
  2. Research with nonviable neonates requires consent from both parents and does not allow a legally authorized representative, while neonates of uncertain viability need either parent and permit one.
  3. An IRB reviewing prisoner research must include a prisoner or prisoner representative, and a majority of its members must have no association with the prison.
  4. Subpart C categories A and B are limited to minimal risk, while categories C and D require consultation by the HHS Secretary and a Federal Register notice.
  5. Prisoner research requires certification to OHRP before it begins, and neither Subpart B nor Subpart C has an FDA counterpart.

Exam traps

The distinctions exam questions on this topic are most often built to test. Know them cold.

  • The father's consent is required only when direct benefit is solely to the fetus, and even then is excused for unavailability, incompetence, temporary incapacity, rape, or incest

  • Nonviable neonates require both parents and no LAR; uncertain viability requires either parent and permits an LAR

  • A prisoner representative is required on the IRB, and a majority must have no association with the prison

  • Categories A and B are limited to minimal risk; C and D require Secretary consultation and Federal Register notice

  • Prisoner research requires OHRP certification before it begins, not merely IRB approval

  • Exemptions do not apply to prisoner-targeted research

Practice quiz

  1. Question 1
    Under 46.204(e), the father's informed consent is required when the research holds out the prospect of direct benefit:
  2. Question 2
    An IRB reviewing research with prisoners must include:
  3. Question 3
    Which 46.306 category may involve greater than minimal risk after Secretary consultation and Federal Register notice?
  4. Question 4
    Before HHS-supported research with prisoners may begin, the institution must:
  5. Question 5
    Research with nonviable neonates requires consent from:

Recap

  • Subpart B: ten conditions in 46.204; the father consents only for direct benefit solely to the fetus; no inducements to terminate, no research role in termination or viability decisions
  • Neonates: uncertain viability, either parent, LAR permitted; nonviable, both parents, no LAR, no added risk, no artificial maintenance; viable, Subpart D
  • Subpart C: prisoner defined by confinement; prisoner representative and majority unassociated; seven findings; four categories with A and B at minimal risk and C and D with Secretary consultation
  • OHRP certification before the research begins; the 2003 epidemiological waiver; subjects who become prisoners
  • FDA has neither subpart; dual coverage applies the HHS subpart

Coming next

Lesson 16, Subpart D, children, and other vulnerable groups.

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This course is for educational purposes only and is not legal, regulatory, or compliance advice. Regulations and guidance change, so confirm every requirement against the current eCFR text, OHRP and FDA guidance, and your institution's IRB policies before relying on it. CIP® is a registered certification mark of Public Responsibility in Medicine and Research (PRIM&R). This course is produced independently by Subthesis and is not affiliated with, endorsed by, or reviewed by PRIM&R or the CIP Council. The instructor is not a Certified IRB Professional. Completing this course does not confer CIP certification, satisfy CIP eligibility requirements, or count as CIP recertification continuing education.