FOR STUDENTS STRUGGLING WITH: Memorizing the 7 Approval Criteria

Level 1 - Visual Learner:

Level 2 - Kinesthetic Learner:

Level 3 - Auditory Learner:

Level 4 - Combination Approach:

FOR STUDENTS STRUGGLING WITH: Understanding Expedited vs. Convened Review

Conceptual Confusion: Many students think "expedited" means "easier" or "lower standards." Not true. Both review types use same approval criteria. Only SPEED differs.

CLARIFICATION CHART:

EXPEDITED:                          CONVENED:
• Minimal-risk category              • Higher-risk OR
• Single reviewer                      beyond categories
• Faster (hours/days)                • Full board
• Reviews same criteria              • Slower (days/weeks)
• Same approval standards            • Reviews same criteria
• Same approval standards

Common Misconception: "Expedited review = lower standards" Correction: "Expedited review = same standards, faster process"

OFFICE HOURS EXERCISE: I'll give you 10 protocol descriptions; you decide expedited vs. convened. Instant feedback on each.

STUDY TIP: Create decision tree flowchart (provided in visual aids) and follow it for every scenario.

FOR STUDENTS STRUGGLING WITH: Conflict of Interest Recusal Rules

Core Confusion: When exactly must someone recuse?

REMEMBER: "Objectivity might be questioned" is the standard. This is a LOW BAR. When in doubt: disclose and recuse.

PRACTICE SCENARIOS:

Scenario A: IRB member consults for drug company for $10,000/year on unrelated work; company sponsors current protocol. Analysis: Even though consulting work is unrelated, financial relationship with sponsor exists. Objectivity might be questioned. Decision: RECUSE

Scenario B: IRB member did PhD under investigator 15 years ago; no recent contact. Analysis: Historical connection might create bias; could go either way. Decision: DISCLOSE and let board decide; leaning toward recusal

Scenario C: IRB member is hospital employee; hospital receives research revenue from sponsor. Analysis: Institutional financial interest affects board's objectivity collectively. Individual member should disclose; board notes institutional interest. Decision: Depends on institutional policy; usually documented conflict

OFFICE HOURS: Bring real or hypothetical conflicts; we'll analyze systematically.

FOR STUDENTS STRUGGLING WITH: Timeline Calculations (7 days, 12 months)

The 7-Day Rule (Adverse Event Reporting):

PRACTICE PROBLEMS:

  1. Event occurs Wednesday 3/15. Deadline? Answer: Wednesday 3/22 (7 days later)

  2. Event occurs Friday 5/2. Deadline? Answer: Friday 5/9

  3. Event occurs on Day 1. Latest report acceptable? Answer: Day 7 (not Day 8)

  4. Reported on Day 8. Compliant? Answer: NO—1 day late

The 12-Month Rule (Continuing Review):

  1. Approved June 15, 2024. Deadline for continuing review? Answer: June 15, 2025

  2. Approved March 1, 2025. Approval expires when? Answer: March 1, 2026 (if continuing review not submitted)

  3. Submitted continuing review June 1, 2025 (2 weeks early). Compliant? Answer: YES—submitted before deadline

  4. Continuing review submitted July 1, 2025. Original approved June 15, 2024. Compliant? Answer: NO—deadline was June 15, 2025; already expired

OFFICE HOURS DRILL: I'll give you 20 date scenarios. You calculate. Instant feedback.

KEY MANTRA: "It's not when you submit; it's the deadline date that matters. After the deadline = violation."

FOR STUDENTS STRUGGLING WITH: IRB Composition Scenarios

The Challenge: Multiple people with different qualifications; determining who fills which role.

SYSTEMATIC APPROACH:

STEP 1: Identify scientist

STEP 2: Identify non-scientist

STEP 3: Identify unaffiliated member

STEP 4: Count total members

STEP 5: Check diversity

OFFICE HOURS GAME: I'll describe 10 fictional IRB members. You classify each and identify any composition problems.

PERSONALIZED STUDY PLAN ADJUSTMENT TEMPLATE

Use this tool to customize your study based on weak areas:

SELF-ASSESSMENT:

Rate your confidence 1-5 (5=very confident):

Topic Confidence Notes
IRB Composition ___ Areas of confusion: _________
RISK-MDP Criteria ___ Areas of confusion: _________
Approval Decisions ___ Areas of confusion: _________
Review Types ___ Areas of confusion: _________
Adverse Event Reporting ___ Areas of confusion: _________
Continuing Review ___ Areas of confusion: _________
Amendments ___ Areas of confusion: _________
21 vs 45 CFR ___ Areas of confusion: _________

WEAK AREA ACTION PLAN:

Identify your lowest-rated topic(s): _________________________

For each weak area, choose study strategy:

Option A - Visual/Spatial:

Option B - Reading/Writing:

Option C - Problem-Solving:

Option D - Social/Discussion:

Option E - Audio/Verbal:

CUSTOMIZED STUDY SCHEDULE:

Monday: Strong areas (confidence 4-5): Quick review

Monday: Weak area (confidence 1-3): Deep dive

Tuesday: Weak area continued

[Continue pattern through Sunday]

QUIZ READINESS CHECKLIST:

Before taking Quiz #2, verify:

OFFICE HOURS FOCUS:

Topics to prioritize in office hours:

Questions to ask:

QUIZ #2 PERFORMANCE ANALYSIS (After Quiz)

After taking Quiz #2, use this reflection:

RESULTS:

QUESTION ANALYSIS:

Which questions did I miss?

  1. Question #____ - Topic: _____________________
  2. Question #____ - Topic: _____________________
  3. Question #____ - Topic: _____________________

PATTERN RECOGNITION:

STUDY PLAN ADJUSTMENT FOR WEEK 4:

Based on Quiz #2 results, I will focus additional study on:

WHAT WORKED WELL:

Study strategies that helped most:

WHAT DIDN'T WORK:

Study strategies to abandon:

ADDITIONAL RESOURCES

CONTACT INFORMATION:

HELPFUL LINKS: