Lesson 22 · IRB and HRPP Administration: From Coordinator to CIP

22. IRB Written Procedures, Records, and Retention: 46.108 and 46.115

55 min

After this lesson you can

  • 1. State the written procedures required by 46.108(a) and 56.108(a) and (b)
  • 2. List the IRB records required by 46.115(a) and 56.115(a) and the retention period
  • 3. Distinguish IRB retention from HIPAA, FDA investigator, and ICH retention periods
  • 4. Describe the FWA, IRB registration, and SOPs as the institutional document architecture
  • 5. Describe electronic records, 21 CFR Part 11, and AAHRPP documentation expectations

Video coming soon

Scheduled for release on October 8, 2026.

IRB Written Procedures, Records, and Retention Rules Explained covers the documentation obligations every IRB carries under HHS, FDA, and HIPAA. This lesson walks through the required written procedures in 46.108, the nine required records in 46.115, and four different retention clocks, plus the FWA, SOPs, and AAHRPP accreditation.

5 Key Facts from This Lesson

  1. IRB records must be kept at least three years after completion of the research under both 45 CFR 46.115(b) and 21 CFR 56.115(b).
  2. HIPAA documentation is kept six years from the date it was created or the date it was last in effect, whichever is later.
  3. FDA investigator records for drugs are kept two years after marketing approval for the indication, or two years after the investigation is discontinued and FDA is notified.
  4. The membership roster must show each member's representative capacity and relationship to the institution, not only their names.
  5. The Federalwide Assurance renews every five years and IRB registration every three, and AAHRPP accreditation is voluntary and does not replace regulatory compliance.

Exam traps

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

  • Three years after completion for IRB records under both HHS and FDA; six years for HIPAA documentation; two years post-approval or post-discontinuation for FDA investigator records

  • The roster must show representative capacity and institutional relationship, not only names

  • The continuing review rationale and the expedited more-than-minimal-risk rationale are required records since 2018

  • FWA renews every five years; IRB registration every three

  • AAHRPP accreditation is voluntary and does not replace regulatory compliance

Practice quiz

  1. Question 1
    Under 45 CFR 46.115(b), IRB records relating to research must be retained for at least:
  2. Question 2
    Which of the following is required in the IRB member list under 46.115(a)(5)?
  3. Question 3
    Which item is NOT among the written procedures required by 46.108(a)(3) and (4)?
  4. Question 4
    HIPAA requires documentation such as authorization waivers to be retained for:
  5. Question 5
    A Federalwide Assurance is valid for:

Recap

  • Written procedures: four required items in 46.108(a)(3) and (4), mirrored in 56.108(a) and (b), plus the general requirement to follow written procedures
  • Records: nine items in 46.115(a); seven in 56.115(a) plus FDA-specific records
  • Retention: 3 years after completion for IRB records; 6 years HIPAA; 2 years FDA investigator; ICH 2 years; adopt the longest
  • Architecture: FWA five years, registration three years, SOPs with version control, templates and forms, electronic systems and Part 11
  • AAHRPP: voluntary, three domains, five-year cycle, documentation benchmark

Coming next

Lesson 23 covers conflict of interest under three rulebooks.

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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.