PART 1: READING ASSIGNMENT WITH ANNOTATION GUIDE

21 CFR Part 56 - Institutional Review Boards

READING TIMELINE:

ANNOTATION PROMPTS - Use these questions to guide your reading:

SECTION 56.101 - SCOPE

SECTION 56.102 - DEFINITIONS

SECTION 56.107 - IRB COMPOSITION

SECTION 56.108 - IRB FUNCTIONS AND OPERATIONS

SECTION 56.109 - IRB REVIEW OF RESEARCH

SECTION 56.110 - EXPEDITED REVIEW

SECTION 56.115-117 - IRB RECORDS

READING ANNOTATION STRATEGY:

  1. Highlight key requirements (use different colors: yellow=composition, blue=approval criteria, pink=procedures)
  2. Write margin notes explaining WHY each rule exists
  3. Circle sections relevant to implementation science
  4. Bracket timeline requirements (7 days, 12 months)
  5. Draw arrows connecting related sections (e.g., link 56.107 composition to 56.108 quorum)

PART 2: IRB COMPOSITION MAPPING EXERCISE

Compare Your Institution's IRB to Federal Requirements

OBJECTIVE: Understand federal requirements by comparing to real-world IRB (your institution or hypothetical).

INSTRUCTIONS: Research or imagine an IRB at your institution (or a typical hospital IRB). Complete the comparison below:

Federal Requirement vs. Your Institution's Practice

REQUIREMENT 1: MINIMUM MEMBERSHIP
Federal Requirement: At least 5 members
Your Institution's IRB Size: _____ members
Compliant? ☐ YES ☐ NO ☐ UNKNOWN

Details from institution's policies: _________________________________

REQUIREMENT 2: SCIENTIFIC MEMBER
Federal Requirement: At least 1 member with clinical research training/experience
Your Institution's Scientific Member(s):
Name (if available) or Title: _______________________________________
Background/Qualification: __________________________________________
Clinical Research Experience? ☐ YES ☐ NO ☐ UNCLEAR
Compliant? ☐ YES ☐ NO

If your institution has multiple scientists, list all:
1. _______________________________________________
2. _______________________________________________
3. _______________________________________________

REQUIREMENT 3: NON-SCIENTIFIC MEMBER
Federal Requirement: At least 1 non-scientist, UNAFFILIATED
Your Institution's Non-Scientific Member:
Name/Title: ________________________________________________________
Professional Background: ___________________________________________
Primary Concerns: ☐ Non-Scientific ☐ Scientific/Healthcare ☐ Unknown
Affiliated Status: ☐ Unaffiliated (external) ☐ Affiliated (employee)
Compliant? ☐ YES ☐ NO

If institution can't identify who fills this role, note: ______________

REQUIREMENT 4: DIVERSITY
Federal Requirement: Gender, professional background, racial/ethnic diversity
Your Institution's IRB Diversity:
Gender Composition: ☐ Both men & women ☐ Only male ☐ Only female ☐ Unknown
Professional Backgrounds (check all that apply):
☐ Physician
☐ Nurse
☐ Pharmacist
☐ Biostatistician
☐ Lawyer
☐ Ethicist
☐ Community member
☐ Other: ________________

Racial/Ethnic Diversity: ☐ Yes, diverse ☐ Limited diversity ☐ Unknown
Overall Assessment of Diversity: _________________________________
Compliant? ☐ YES ☐ NO ☐ PARTIAL

Your Analysis: Does this IRB adequately represent varied perspectives?
________________________________________________________________

REQUIREMENT 5: QUORUM
Federal Requirement: Majority of members + at least 1 unaffiliated
Your Institution's Quorum Policy: ___________________________________
How is quorum verified: ____________________________________________
What happens if quorum not met: ____________________________________

Test Case: If your institution's IRB has 7 members, and 4 show up
(including 1 unaffiliated), is quorum present?
Your Answer: ☐ YES ☐ NO
Correct Answer: YES (4 is more than half of 7; 1 unaffiliated present)
Did you get it right? ☐ YES ☐ NO

Strengths of Your Institution's Composition:

Areas That Could Be Strengthened:

PART 3: CASE STUDY - PROTOCOL EVALUATION EXERCISE

Apply RISK-MDP to Evaluate a Mock Protocol

PROTOCOL TITLE: "Effects of Team-Based Care Coordination on Diabetes Control in Rural Primary Care"

PROTOCOL SUMMARY: A cluster-randomized trial in 8 rural primary care practices serving underinsured patients with poorly-controlled Type 2 diabetes. Four practices randomized to intervention (team-based care coordination with nurse navigator, social worker consultation), four to usual care. Study duration: 12 months. Primary outcome: HbA1c change. Sample size: 200 subjects (25 per site).

POPULATION: Adult patients (18-65) with Type 2 diabetes, HbA1c >8.5%, receiving care at participating practices, English or Spanish speaking.

EXCLUSION CRITERIA: Pregnancy, end-stage renal disease, recent cardiovascular event (within 3 months).

INTERVENTION: Care coordination team (nurse navigator, social worker, pharmacist) co-located at clinic; meets with subjects monthly; coordinates with primary care provider.

PROCEDURES:

RISKS:

BENEFITS:

INFORMED CONSENT: Draft exists; subjects to receive consent before enrollment

MONITORING PLAN: Monthly review of HbA1c trends at care coordination team meeting; quarterly IRB updates; adverse event reporting for hospitalizations related to diabetes

YOUR TASK: Evaluate this protocol using RISK-MDP

Complete the evaluation matrix below:

RISK-MDP EVALUATION MATRIX

R - RISK IS MINIMIZED
─────────────────────────────────────────────────
Criteria Assessment:
☐ Procedures justified scientifically?
☐ No unnecessary procedures?
☐ Risk proportionate to benefit?
☐ Use existing procedures where possible?

Protocol Assessment: _____________________________________________

RISK MINIMIZED? ☐ YES ☐ NO ☐ PARTIALLY - Explain:
____________________________________________________________________


I - INFORMED CONSENT ADEQUATE
─────────────────────────────────────────────────
Criteria Assessment:
☐ Study purpose clear?
☐ Risks described with frequencies?
☐ Benefits described?
☐ Alternatives listed?
☐ Confidentiality protections explained?
☐ Right to withdraw stated?
☐ Contact info provided?
☐ Language understandable?

Key Question: What risks should consent specifically mention?
1. ________________________________________________________________
2. ________________________________________________________________
3. ________________________________________________________________

INFORMED CONSENT ADEQUATE? ☐ YES ☐ NO ☐ NEEDS REVISION - Explain:
____________________________________________________________________


S - SELECTION EQUITABLE
─────────────────────────────────────────────────
Inclusion Criteria Assessment:
Are inclusion criteria justified? ✓ or ✗: _________________________

Exclusion Criteria Assessment:
Age 18-65 only: Justified? ☐ YES ☐ NO (Why/Why not?) ____________
English OR Spanish: Justified? ☐ YES ☐ NO ________________________
Pregnant excluded: Justified? ☐ YES ☐ NO _________________________
ESRD excluded: Justified? ☐ YES ☐ NO ______________________________

Equitable Selection Assessment:
☐ Process fair?
☐ Selection targets population with disease (equitable)?
☐ Any unnecessary exclusions?
☐ Vulnerable population (rural, underinsured)—extra protections?

SELECTION EQUITABLE? ☐ YES ☐ NO ☐ PARTIALLY - Explain:
____________________________________________________________________


K - KNOWLEDGEABLE REVIEW
─────────────────────────────────────────────────
IRB Expertise Required:
☐ Diabetes management
☐ Care coordination models
☐ Implementation science
☐ Qualitative research methods
☐ Clinical trial design
☐ Cluster randomization design

Does typical IRB have this expertise? ☐ YES ☐ NO ☐ NEED CONSULTANT

What external expertise would strengthen review? ________________
____________________________________________________________________

KNOWLEDGEABLE REVIEW POSSIBLE? ☐ YES ☐ NO - Explain:
____________________________________________________________________


M - MONITORING ADEQUATE
─────────────────────────────────────────────────
Monitoring Plan Assessment:
What will be monitored? _____________________________________________
How frequently? ____________________________________________________
What are stopping rules (if any)? __________________________________
How will protocol deviations be tracked? __________________________
Data quality procedures? ____________________________________________
AE reporting procedures? _____________________________________________
Continuing review planned? ☐ YES ☐ NO

Is monitoring plan specific enough? ☐ YES ☐ NO - Explain:
____________________________________________________________________

MONITORING ADEQUATE? ☐ YES ☐ NO ☐ NEEDS DETAIL - Explain:
____________________________________________________________________


D - DATA SAFETY & INTEGRITY
─────────────────────────────────────────────────
Data Protection Assessment:
Privacy Protections:
☐ De-identification procedures?
☐ Secure storage (locked/encrypted)?
☐ Limited access procedures?
☐ Healthcare data security?

Data Integrity Procedures:
☐ Audit trail for changes?
☐ Version control for data?
☐ Backup procedures?
☐ Breach notification plan?

Cybersecurity (E6(R3)):
☐ Digital data encryption?
☐ Access controls?
☐ Backup systems?
☐ Incident response plan?

Specific Risks in This Study:
How will patient depression screening data be protected? ___________
How will diabetes control data (HbA1c) be protected? _______________
How will social/economic data be protected? _____________________

DATA SAFETY & INTEGRITY ADEQUATE? ☐ YES ☐ NO - Explain:
____________________________________________________________________


P - VULNERABLE POPULATIONS
─────────────────────────────────────────────────
Vulnerable Population Identification:
☐ Rural population (social vulnerability)?
☐ Underinsured/low-income (economic vulnerability)?
☐ Diabetes patients (health vulnerability)?
☐ Non-English speakers (language barrier)?

Extra Safeguards Needed:
☐ Community advisory board input?
☐ Culturally appropriate materials?
☐ Language services (Spanish translation/interpretation)?
☐ Easy-to-read consent form?
☐ Extra monitoring for coercion?

Are extra safeguards included in protocol? ☐ YES ☐ NO

VULNERABLE POPULATIONS PROTECTED? ☐ YES ☐ NO - Explain:
____________________________________________________________________

OVERALL PROTOCOL ASSESSMENT

SUMMARY TABLE:

Criterion Met Comments
R - Risk Minimized ☐
I - Informed Consent ☐
S - Selection Equitable ☐
K - Knowledgeable Review ☐
M - Monitoring ☐
D - Data Safety ☐
P - Vulnerable Pop. ☐

ALL 7 CRITERIA MET? ☐ YES ☐ NO

IRB RECOMMENDATION: ☐ APPROVE (all criteria clearly met) ☐ CONDITIONAL APPROVAL with conditions:

☐ DISAPPROVE due to: _____________________________________________

RECOMMENDED REVIEW TYPE: ☐ Expedited (minimal-risk, straightforward) ☐ Convened (vulnerable population, complex)

JUSTIFICATION:

PART 4: WEEK 4 PREPARATION CHECKLIST

By the end of this week, to prepare for Week 4:

PRE-WEEK-4 ASSIGNMENTS:

OPTIONAL PREP FOR WEEK 4:

Questions/Clarifications:

STUDY TIPS FOR SUCCESS

  1. Don't skip the reading. 21 CFR Part 56 is dense, but essential. Read actively using annotation guide.

  2. Do the mapping exercise. Understanding your own institution's IRB makes federal requirements concrete.

  3. Engage with case study. Real-world application cements learning better than passive reading.

  4. Take QUIZ #2 seriously. Use practice bank this week; don't wait until Sunday.