Free 26-Lesson Course

IRB and HRPP AdministrationFrom Coordinator to CIP

A complete lecture course on Institutional Review Board administration, built on PRIM&R's public 2025 CIP Body of Knowledge and Exam References. The lessons follow the exam blueprint across its three domains, and every lesson cites the regulation it teaches so you can verify it yourself. Each lesson page adds the learning objectives, the exam traps to avoid, a recap, and practice questions with explained answers.

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26narrated lessons
25 h 13 mintotal runtime
183practice questions
6 of 26 videos released so far; new lessons added as they go live
Free Course
IRB and HRPP
Administration
Produced by Subthesis

Course at a glance

26
Video lessons
45 to 60 minutes each
3
Exam domains
Weighted 29, 54, and 17 percent, as the exam is
183
Practice questions
Every answer explained, with its citation

Course outline

26 lessons across the three exam domains, plus an orientation and a capstone · ~25 hours total · click any lesson to start

Module 0: Course Orientation

  1. Lesson 0

    How the CIP Exam Works: Eligibility, Blueprint, Study Plan

    54 min
    • Describe the exam structure, timing, scoring, and delivery
    • State the eligibility rules and what counts as relevant experience
    • Map the three domains and their weights to the 26 lessons

Module 1: Domain 1: Human Subjects Protection (29%)

  1. Lesson 1

    Why IRBs Exist: Tuskegee, Nuremberg, and the Rules They Wrote

    65 min
    • Sequence the major research ethics scandals and the response to each
    • Explain how the National Research Act of 1974 created IRBs and the National Commission
    • Trace 45 CFR 46 from 1974 through 1991 to the 2018 Requirements
  2. Lesson 2

    The Belmont Report Explained: Three Principles, Three Applications

    58 min
    • State the three principles and the application paired with each
    • Explain the boundary between practice and research
    • Apply the three components of consent: information, comprehension, voluntariness
  3. Lesson 3

    Nuremberg, Helsinki, CIOMS, and ICH GCP: The International Codes

    66 min
    • State the ten principles of the Nuremberg Code and their origin
    • Explain Helsinki's authorship, audience, and positions on placebo, post-trial access, vulnerable groups, and registration
    • Describe the CIOMS guidelines and their focus on low-resource settings
  4. Lesson 4

    The Common Rule Explained: 45 CFR 46 Definitions That Decide Everything

    74 min
    • State to whom and to what 45 CFR 46 applies and how the FWA extends it
    • Recite and apply the definitions of research, human subject, minimal risk, and the related terms
    • Name the four activities deemed not to be research
  5. Lesson 5

    FDA Human Subject Regulations: 21 CFR 50, 56, 312, and 812 Explained

    76 min
    • State when FDA regulations apply and how that differs from Common Rule applicability
    • Contrast the FDA definitions of human subject, clinical investigation, and test article with the HHS definitions
    • Describe the IND framework in 21 CFR 312, including exemptions and the roles of sponsor, investigator, and IRB
  6. Lesson 6

    HUDs, Expanded Access, and Emergency Use: FDA's Special Pathways

    50 minReleases Sep 18
    • Explain the Humanitarian Use Device designation and the IRB's role in HDE use
    • Distinguish the expanded access categories in 21 CFR 312 Subpart I
    • Apply the emergency use exemption from IRB review and the emergency exception from consent at 50.23
  7. Lesson 7

    DOD, DOJ, NIH, VA, and EPA: How Agencies Layer the Common Rule

    55 minReleases Sep 21
    • Explain how Common Rule agencies codify Subpart A and add their own requirements
    • Describe Department of Defense additional protections for research involving service members
    • Describe Department of Justice and Bureau of Prisons requirements for research with prisoners

Module 2: Domain 2: IRB Responsibilities (54%)

  1. Lesson 8

    IRB Membership, Quorum, and Authority: 45 CFR 46.107 to 46.113

    50 minReleases Sep 22
    • State the membership requirements of 45 CFR 46.107 and 21 CFR 56.107
    • Define quorum and the conditions under which a convened IRB may act
    • Describe the roles of chair, alternates, consultants, and the Institutional Official
  2. Lesson 9

    The 8 Exemption Categories and Limited IRB Review: 45 CFR 46.104

    60 minReleases Sep 23
    • State all eight exemption categories in 45 CFR 46.104(d) with their conditions
    • Explain limited IRB review and when it is required
    • Apply the restrictions on exemptions for research with children, prisoners, and pregnant women
  3. Lesson 10

    Expedited, Full Board, and Continuing Review: The 9 Categories and 46.109(f)

    60 minReleases Sep 24
    • State the nine expedited review categories and the conditions for using the expedited procedure
    • Explain who may conduct expedited review and what they may and may not decide
    • Describe convened review and when it is required
  4. Lesson 11

    The Criteria for IRB Approval: 45 CFR 46.111 Line by Line

    55 minReleases Sep 25
    • Recite the criteria for approval in 45 CFR 46.111(a)(1) through (a)(8) and (b)
    • Explain how an IRB evaluates risk minimization and the reasonableness of risks relative to benefits
    • Apply the equitable selection criterion, including its attention to vulnerable populations
  5. Lesson 12

    Informed Consent Elements, Key Information, Broad Consent, and Waivers

    60 minReleases Sep 28
    • State the general requirements for informed consent in 45 CFR 46.116(a)
    • Recite the basic elements in 46.116(b) and the additional elements in 46.116(c)
    • Explain broad consent under 46.116(d) and its relationship to exemption categories 7 and 8
  6. Lesson 13

    Documenting Consent: Short Form, Waivers, LARs, Assent, and eConsent

    55 minReleases Sep 29
    • State the documentation requirements of 45 CFR 46.117 and 21 CFR 50.27
    • Apply the short form procedure, including who signs what
    • Apply the three waiver-of-documentation criteria in 46.117(c) and the two in 21 CFR 56.109(c)
  7. Lesson 14

    HIPAA in Research, Certificates of Confidentiality, FERPA, and GINA

    60 minReleases Sep 30
    • Distinguish privacy from confidentiality and identify the IRB criterion governing each
    • Explain how the HIPAA Privacy Rule applies to research: covered entities, PHI, authorization, waiver, limited data sets, de-identification, preparatory to research, and decedents
    • Explain Certificates of Confidentiality, what they protect, and their exceptions
  8. Lesson 15

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

    55 minReleases Oct 1
    • 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
  9. Lesson 16

    Subpart D Children: 404 to 407, Assent, Permission, and Wards

    60 minReleases Oct 2
    • Define children, assent, permission, and guardian under 45 CFR 46.402 and 21 CFR 50.3
    • Apply the four risk categories in 46.404 through 46.407 and their FDA counterparts in 50.51 through 50.54
    • State the assent and permission rules in 46.408 and 50.55, including when each may be waived
  10. Lesson 17

    Adverse Events vs Unanticipated Problems: The OHRP Test and FDA Safety Clocks

    55 minReleases Oct 3
    • Define adverse event, serious adverse event, unexpected adverse event, and suspected adverse reaction
    • Apply the three-part OHRP test for an unanticipated problem involving risks to subjects or others
    • Distinguish which adverse events must be reported to the IRB and by whom
  11. Lesson 18

    Noncompliance, Research Misconduct, and IRB Suspensions Explained

    55 minReleases Oct 5
    • Define noncompliance, serious noncompliance, and continuing noncompliance and describe how an IRB handles each
    • Distinguish protocol deviations from violations and from unanticipated problems
    • Explain research misconduct under 42 CFR 93: definition, standard of proof, process, and the roles of the RIO and ORI
  12. Lesson 19

    IRB Meeting Minutes: Exactly What 45 CFR 46.115 Requires

    50 minReleases Oct 6
    • State the minute content required by 45 CFR 46.115(a)(2) and 21 CFR 56.115(a)(2)
    • Record attendance, quorum, recusals, and votes in the form regulators expect
    • Document controverted issues, the basis for requiring changes or disapproval, and risk and category determinations
  13. Lesson 20

    From Intake to Approval Letter: Three IRB Protocols Worked End to End

    60 minReleases Oct 7
    • Sequence the determinations an IRB office makes on a new submission from intake to approval letter
    • Apply the Domain 2 rules to three worked protocols of different types
    • Produce the documentation trail each determination requires

Module 3: Domain 3: Institutional Responsibilities (17%)

  1. Lesson 21

    Single IRB, Reliance Agreements, and Local Context: 45 CFR 46.114

    55 minReleases Oct 7
    • 1. State the single IRB requirement in 46.114 and its exceptions
    • 2. Distinguish the NIH sIRB policy, the Common Rule requirement, and FDA 56.114
    • 3. Explain reliance agreements, IRB Authorization Agreements, and SMART IRB
  2. Lesson 22

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

    55 minReleases Oct 8
    • 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
  3. Lesson 23

    Conflict of Interest in Research: 42 CFR 50 Subpart F, 21 CFR 54, and IRB Members

    55 minReleases Oct 10
    • 1. State the PHS FCOI rule: SFI threshold, disclosure, determination, management, reporting
    • 2. State the FDA financial disclosure requirements in 21 CFR 54
    • 3. Apply the IRB member conflict rule in 46.107(e) and 56.107(e)
  4. Lesson 24

    Reporting to OHRP and FDA, Compliance Oversight, and HRPP Education Programs

    55 minReleases Oct 11
    • 1. State what an institution must report to OHRP and FDA, when, and through whom
    • 2. Describe OHRP and FDA compliance oversight processes and possible outcomes
    • 3. Identify intersecting reporting obligations: ClinicalTrials.gov, FCOI, misconduct, state law

Module 4: Capstone: Exam Strategy and Mixed Review

  1. Lesson 25

    CIP Exam Strategy, 50-Question Mixed Review, and Recertification

    60 minReleases Oct 5
    • 1. Execute the CIP application, scheduling, and test-day process without error
    • 2. Allocate study time by domain weight and by personal weakness
    • 3. Apply answer-selection strategy for one-best-answer regulatory items

Questions, corrections, or a topic the course should cover?

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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.