ACTIVITY 1: CONSENT FORM SCAVENGER HUNT (10 minutes)

Learning Objective: Students will identify all 11 required elements in a real consent form.

Materials Needed:

• Sample flawed consent form (provided below)
• Printed checklist (1 per student or pair)
• Highlighters or colored pens

Setup (2 minutes):

1. Distribute sample consent form and element checklist
2. Divide class into pairs
3. Explain: "You're an IRB reviewer. Find evidence of each element on this form."

Sample Flawed Consent Form (excerpt):

SAMPLE FLAWED FORM: "Phase 2 Study of XYZ-101 for Arthritis"

What is the purpose of this study? This is a research study to test how XYZ-101 (an experimental anti-inflammatory medication) affects symptoms of rheumatoid arthritis. The study will last 12 weeks.

What will you do? If you enroll, you will visit the clinic weekly for blood tests and symptom assessment. You'll receive either the study drug or placebo (an inactive pill).

Risks: Common side effects include nausea, mild headache, and joint pain. Liver enzyme elevation (hepatotoxicity) has been observed in animal studies and may occur in humans. Rare allergic reactions are possible.

Benefits: Many subjects experience improvement in symptoms. However, some subjects see no benefit.

Confidentiality: Your information will be kept private. The research team will maintain a code linking your name to study data.

Voluntary: You can withdraw from this study anytime without penalty to your medical care.

Questions: Contact Dr. Smith at 555-1234 or the Research Office at 555-5678.

Costs: There are no costs to you for study medication. Your insurance will be billed for clinic visits.

Activity (6 minutes):

Student pairs review form and check off elements on this checklist:

• Element 1: Risks - YES / NO / UNCLEAR Evidence: _______________

• Element 2: Benefits - YES / NO / UNCLEAR Evidence: _______________

• Element 3: Alternatives - YES / NO / UNCLEAR Evidence: _______________

• Element 4: Confidentiality - YES / NO / UNCLEAR Evidence: _______________

• Element 5: Voluntary & Withdraw - YES / NO / UNCLEAR Evidence: _______________

• Element 6: Contact Info - YES / NO / UNCLEAR Evidence: _______________

• Element 7: Compensation/Injury - YES / NO / UNCLEAR Evidence: _______________

• Element 8: FDA Contact - YES / NO / UNCLEAR Evidence: _______________

• Element 9: Costs - YES / NO / UNCLEAR Evidence: _______________

• Element 10: Study Termination - YES / NO / UNCLEAR Evidence: _______________

• Element 11: Additional Material Info - YES / NO / UNCLEAR Evidence: _______________

Debrief (2 minutes):

• Instructor asks: "What's missing?"
• Students identify missing elements (Element 8: FDA contact, Element 7: injury compensation, Element 11: randomization to placebo, Element 3: alternatives to treatment)
• Discuss: Why is Element 11 missing? (Randomization/placebo assignment is material to decision)

Key Takeaway: "Element 11 catches design features that aren't explicitly covered elsewhere. Randomization, biobanking, genetic testing, study duration—all belong in Element 11 if material to the decision."

ACTIVITY 2: RED FLAG IDENTIFICATION (8 minutes)

Learning Objective: Students will identify regulatory violations and consent form deficiencies.

Materials Needed:

• Provided consent form excerpts with violations
• Violation identification worksheet

Setup (1 minute): Explain: "FDA inspectors look for specific red flags. Can you spot them?"

Sample Excerpts with Violations:

Excerpt A (Exculpatory Language)

"I understand that the investigator is not responsible for any injuries I may experience from the study drug and I will not pursue legal remedies."

Ask Students: "Is this acceptable?"

• Answer: NO - exculpatory language forbidden (§50.20(b)(4))

Excerpt B (Missing Confidentiality Limit)

"Your information will be kept completely confidential."

Ask Students: "Is this complete?"

• Answer: NO - doesn't address FDA access, retention, breach notification

Excerpt C (Vague Contact Info)

"For questions, contact the research office."

Ask Students: "Is this adequate?"

• Answer: NO - needs named individual, phone, hours

Excerpt D (Therapeutic Misconception Risk)

"This drug has been shown to cure arthritis in many patients. You will likely experience complete symptom relief."

Ask Students: "What's wrong?"

• Answer: Overstates benefits, creates therapeutic misconception

Excerpt E (Missing Element)

Form includes: Risks, Benefits, Alternatives, Confidentiality, Voluntary, Contact, Costs Form is MISSING: Element 7 (Compensation/Injury), Element 8 (FDA), Element 10 (Termination), Element 11 (Additional Info)

Ask Students: "Which elements are absent?"

Activity (5 minutes):

Hand out "Red Flag Detection Worksheet":

RED FLAG DETECTION WORKSHEET

For each excerpt, identify:

1. Violation? (Yes/No)
2. Type: (Exculpatory / Missing element / Inadequate disclosure / Comprehensibility / Other)
3. Regulatory Citation
4. How to fix it?

Instructors provide 3-4 additional excerpts for students to evaluate

Debrief (2 minutes):

• Quick go-through of each excerpt
• Discuss pattern: Element 7, 8, 11 most commonly missing
• Discuss: Exculpatory language is NEVER acceptable

Key Takeaway: "FDA inspectors have a checklist. The most frequent violations: missing Element 11 (design features), missing injury/compensation information (Element 7), and undisclosed FDA access (Element 4 or 8)."

ACTIVITY 3: VULNERABLE POPULATION MATCHING GAME (7 minutes)

Learning Objective: Students will apply enrollment rules to different vulnerable populations.

Materials Needed:

• Matching worksheet (printed or projected)
• Population/Scenario cards

Setup (1 minute): Divide class into two teams or pairs.

Activity (5 minutes):

MATCHING GAME: Can These Subjects Be Enrolled?

Column A: Scenarios

1. A 15-year-old with asthma in a minimal-risk survey study about school experiences
2. A pregnant woman in a Phase 1 safety study of a new drug (minimal fetal risk)
3. A prisoner in a study testing prison security procedures
4. An 8-year-old in a Phase 2 study of asthma drug WITH direct therapeutic benefit
5. An elderly adult with cognitive impairment and no LAR in an IND drug trial

Column B: Answers A. YES - Enrollment appropriate
B. NO - Enrollment prohibited
C. YES with additional protections - Enrollment possible with safeguards

Correct Answers:

1. → A (YES - parental consent + child assent, minimal risk)
2. → A (YES - minimal fetal risk permits participation)
3. → B (NO - research designed to benefit prison, not subject)
4. → A (YES - direct benefit to child justifies minor increase over minimal risk)
5. → B (NO - incapacitated adult needs LAR consent; cannot proceed without LAR)

Scoring:

• 5/5 Correct: Expert level
• 4/5 Correct: Proficient
• 3/5 Correct: Developing
• <3: Review vulnerable population rules

Debrief (1 minute): Walk through correct answers. Emphasize:

• Children: Risk depends on benefit
• Pregnant women: Generally minimal-risk only
• Prisoners: Minimal-risk only; no institutional benefit studies
• Cognitively impaired: Need LAR consent

ACTIVITY 4: QUICK-FIRE Q&A ON EXCEPTIONS (5 minutes)

Learning Objective: Students will rapidly recall exception criteria and identify when exceptions apply.

Format: Rapid-fire questions; instructor reads, students respond (think-pair-share or raise hands)

QUICK-FIRE QUESTIONS:

Question 1: "Can you skip informed consent entirely in a minimal-risk chart review?"

• Answer: "Only if ALL four criteria for full waiver are met AND IRB approves. Not automatic."
• Time allowed: 30 sec

Question 2: "A non-English speaker participates in IND study. Can you use family as interpreter instead of professional?"

• Answer: "No - qualified, independent interpreter required per best practice."
• Time allowed: 30 sec

Question 3: "Patient arrives unconscious in ER with acute myocardial infarction. Can you enroll in experimental thrombolytic trial without prior consent?"

• Answer: "Yes, if life-threatening emergency AND FDA approves AND no LAR reachable AND no alternative. Must obtain consent ASAP."
• Time allowed: 45 sec

Question 4: "Can a subject's consent form include the statement: 'I waive compensation for study injuries'?"

• Answer: "NO - exculpatory language FORBIDDEN."
• Time allowed: 30 sec

Question 5: "A consent form uses very technical medical language (pharmacokinetics, hepatotoxicity, LC-MS analysis). All 11 elements are included. Is this acceptable?"

• Answer: "No - must be comprehensible to general population. Likely FDA violation."
• Time allowed: 45 sec

Question 6: "Can a 6-year-old sign a consent form and participate without parental consent?"

• Answer: "No - parent/guardian must consent. Child's assent encouraged if capable, but not substitute for parental consent."
• Time allowed: 45 sec

Question 7: "A consent form doesn't mention that the study is randomized with 50% chance of placebo. Is this acceptable?"

• Answer: "No - randomization/placebo is material info belonging in Element 11."
• Time allowed: 45 sec

Question 8: "How do you establish whether a study poses 'minimal risk' vs. 'more than minimal risk'?"

• Answer: "Compare probability and magnitude of harm to everyday activities or routine medical exams. ≤ everyday risk = minimal."
• Time allowed: 60 sec

Scoring/Feedback:

• Instructor praises correct quick responses
• Offers clarification for missed questions
• Emphasizes: "These are the types of questions on the actual SOCRA exam."

Key Takeaway: "Exceptions are rare. Default answer: 'Informed consent required.' Only when specific criteria ALL met can you proceed otherwise."

TIMING SUMMARY

FACILITATION TIPS

Activity 1 Tips

• Pre-select the flawed form strategically—it should have 3-5 obvious violations
• Pairs work better than individuals (peer discussion reinforces learning)
• Use highlighters so violations are visible
• Debrief should emphasize: "Element 11 is the trap"

Activity 2 Tips

• Read excerpts aloud so students with text processing challenges can participate
• Give 30-45 seconds per excerpt
• Discuss: "Why is exculpatory language forbidden?" (power imbalance, waives rights)
• Emphasize: "FDA flagged this in 3 inspections at our institution"

Activity 3 Tips

• Make it competitive (team point system) to increase engagement
• If students miss answers, DON'T just give answer—ask guiding question: "What does the regulation say about prisoners?"
• Reference specific citations (§50.50, §50.60)

Activity 4 Tips

• Go fast—this mimics exam pressure
• Celebrate correct quick answers ("Exactly right, and fast!")
• If wrong, ask "Who agrees?" to generate peer discussion
• Leave 1 question for the very end to end on a high note

LEARNING OUTCOMES ASSESSMENT

After completing all 4 activities, students should be able to:

✓ Identify all 11 required elements in a consent form
✓ Spot common violations (exculpatory language, missing elements, vague contact info)
✓ Apply enrollment rules to vulnerable populations
✓ Recall exception criteria and assess when they apply

HOMEWORK ASSIGNMENT (to complete after class)

1. Consent Form Review Exercise: Review your institution's actual consent form (or provided sample). Identify all 11 elements. Mark any deficiencies.

2. Violation Identification: Write 3 sentences: "The most significant gap I found in the consent form was Element _____, which...". Suggest 1 improvement.

3. Reflection Question: "How does my institution's consent process differ from the regulatory minimum? What's done better? What needs work?"