Table of Contents

1. ASSIGNMENT 1: CONSENT FORM REVIEW EXERCISE (1 hour)
2. ASSIGNMENT 2: VIOLATION IDENTIFICATION EXERCISE (1 hour)
3. ASSIGNMENT 3: REFLECTION & INSTITUTIONAL ANALYSIS (1 hour)
4. ASSIGNMENT 4: CONSENT FORM CREATION EXERCISE (1 hour)
5. ASSIGNMENT 5: HOMEWORK WRAP-UP QUIZ (30 minutes)
6. READING ASSIGNMENT FOR WEEK 3
7. FINAL STUDY TIPS FOR SUCCESS
8. RESOURCES FOR ADDITIONAL HELP
9. SUBMISSION CHECKLIST

ASSIGNMENT 1: CONSENT FORM REVIEW EXERCISE (1 hour)

Objective: Apply the 11 elements framework to a real consent form.

Instructions: You will review either:

• Your institution's actual consent form (preferred), OR
• The sample form provided below

SAMPLE CONSENT FORM FOR REVIEW:

INVESTIGATIONAL DRUG STUDY CONSENT FORM

Study Title: A Phase 2 Randomized, Placebo-Controlled Study of ABC-123 in Patients with Moderate Rheumatoid Arthritis

Principal Investigator: Dr. Michael Johnson, MD
Rheumatology Department, Research Hospital

PURPOSE OF THE STUDY

You are invited to participate in a research study to evaluate the safety and effectiveness of an investigational drug called ABC-123 in treating rheumatoid arthritis (RA). Approximately 120 subjects will participate in this study.

WHAT IS INVOLVED IN THIS STUDY?

If you decide to participate, you will be in this study for approximately 12 weeks. You will visit the clinic weekly. At each visit:

• Blood will be drawn (approximately 4 tubes)
• Your RA symptoms will be assessed
• You will receive either the study drug or placebo pill

You will also be required to maintain a daily symptom diary.

RISKS OF THIS STUDY

Common side effects reported with ABC-123 include nausea, headache, and mild joint pain. These side effects are usually mild and resolve within a few days. Some subjects may experience loss of appetite. In pre-clinical studies, ABC-123 showed potential liver toxicity at high doses. We will monitor your liver function with blood tests to ensure safety.

BENEFITS OF THIS STUDY

Many subjects with RA have reported improvement in symptoms when taking ABC-123. However, some subjects do not experience benefit. You may or may not personally benefit from participating in this study.

CONFIDENTIALITY

Your research information will be kept confidential. Your name will be replaced with a study number, and your research records will be stored in a locked cabinet accessible only to the research team.

VOLUNTARY PARTICIPATION

Your participation is voluntary. You may choose not to participate or may withdraw from the study at any time without affecting your medical care.

CONTACT FOR QUESTIONS

If you have questions about this study, please contact Dr. Johnson at 555-123-4567.

COSTS

There is no cost to you for study-related blood tests or clinic visits. Any other medical care costs will be your responsibility or billed to your insurance.

REVIEW EXERCISE: Element Checklist

Using the form above, complete this checklist:

Element 1: Statement of Risks

• Addressed clearly
• Vague or incomplete
• Missing entirely

Comments: _______________________________________________________________

Element 2: Statement of Benefits

• Direct benefit discussed
• No-benefit statement present
• Clear distinction between benefit types
• Exaggerates benefits
• Missing entirely

Comments: _______________________________________________________________

Element 3: Disclosure of Alternatives

• Discusses standard RA treatments
• Compares study drug to other options
• Mentions "watchful waiting" or do-nothing option
• Inadequate (e.g., "other treatments available")
• Missing entirely

Comments: _______________________________________________________________

Element 4: Confidentiality Protections

• Describes coding/de-identification method
• Addresses FDA access to records
• Addresses data retention duration
• Addresses breach notification
• Too vague ("will be kept confidential")
• Missing entirely

Comments: _______________________________________________________________

Element 5: Voluntary Participation & Right to Withdraw

• Clear statement of voluntary nature
• Explicit right to withdraw
• Addresses consequences (or lack thereof)
• Vague or implied coercion
• Missing entirely

Comments: _______________________________________________________________

Element 6: Contact Information for Questions/Injuries

• Named investigator with phone/email
• IRB contact information
• Hours of availability
• Generic or inadequate contact info
• Missing entirely

Comments: _______________________________________________________________

Element 7: Compensation & Injury Information

• Compensation amount and schedule stated
• Study-related injury treatment addressed
• Clear about who pays for injury care
• Vague or missing compensation details
• Missing entirely

Comments: _______________________________________________________________

Element 8: FDA Contact (if >minimal risk)

• FDA office contact information provided
• Purpose (questions about subject rights) clear
• Missing entirely

Comments: _______________________________________________________________

Element 9: Statement About Costs

• Specific costs addressed
• Clarifies what subject pays vs. insurance
• Vague or incomplete
• Missing entirely

Comments: _______________________________________________________________

Element 10: Study Termination

• States sponsor/investigator can end study
• Addresses notification procedures
• Discusses post-termination care
• Vague or missing
• Missing entirely

Comments: _______________________________________________________________

Element 11: Additional Material Information

• Study design features explained (randomization, placebo, duration)
• Any biobanking/genetic testing disclosed
• Medication restrictions disclosed
• Pregnancy/nursing status requirements disclosed
• Long-term follow-up requirements disclosed
• Commercial potential mentioned
• Incomplete (missing design features)
• Missing entirely

Comments: _______________________________________________________________

SUMMARY OF REVIEW

Total Elements Addressed: _____ / 11

Strongest Elements: _________________________________________________________

Weakest Elements: __________________________________________________________

One Key Deficiency: _________________________________________________________

One Recommendation for Improvement: _________________________________________

ASSIGNMENT 2: VIOLATION IDENTIFICATION EXERCISE (1 hour)

Objective: Identify regulatory violations in consent forms.

Instructions: For each excerpt below, identify:

1. Is there a violation? (Yes/No)
2. Type of violation
3. Regulatory citation
4. How to fix it

Excerpt A: The Researcher's Form

"Subjects who experience adverse events acknowledge that they will not pursue legal remedies. The investigator assumes no liability for any injuries sustained during the study."

Violation? YES / NO

Type: _________________________________________________________________

Citation: ______________________________________________________________

Fix: ___________________________________________________________________

Answer Key:

• Violation: YES
• Type: Exculpatory language (waives legal rights)
• Citation: 21 CFR 50.20(b)(4)
• Fix: Remove exculpatory language. Replace with: "If you experience a study-related injury, inform Dr. [name] immediately. Medical care will be provided. You retain all legal rights."

Excerpt B: The Incomplete Form

"Your information will be completely protected and kept confidential according to federal law."

Violation? YES / NO

Type: _________________________________________________________________

Citation: ______________________________________________________________

Fix: ___________________________________________________________________

Answer Key:

• Violation: YES (incomplete)
• Type: Inadequate confidentiality statement (§50.25(a)(4))
• Citation: 21 CFR 50.25(a)(4)
• Fix: Add specifics: "Your data will be coded with a study number. FDA inspectors may review identifiable records. Data will be retained for 7 years, then destroyed. If a breach occurs, you'll be notified per state law."

Excerpt C: The Vague Form

"For questions about your participation, please contact our research office."

Violation? YES / NO

Type: _________________________________________________________________

Citation: ______________________________________________________________

Fix: ___________________________________________________________________

Answer Key:

• Violation: YES
• Type: Inadequate contact information (§50.25(a)(6))
• Citation: 21 CFR 50.25(a)(6)
• Fix: Provide named individuals: "For study questions: Dr. Jane Smith, 555-1234, jane@research.edu (M-F 8am-5pm). For rights questions: IRB Office, 555-5678, irb@institution.edu (24/7 emergency line)."

Excerpt D: The Missing Element Form

This form includes: Risks, Benefits, Alternatives, Confidentiality, Voluntary Participation, Contact Info, Compensation, and Costs.

What is MISSING?

Answer Key:

• Missing: Elements 8, 10, and 11
• Element 8 (FDA contact): For more-than-minimal-risk studies, must include FDA contact info
• Element 10 (Study Termination): Must state that sponsor/investigator can end study and explain how subjects will be notified
• Element 11 (Additional Information): Study design features (randomization, placebo chance, 12-week duration) are material and must be disclosed

ASSIGNMENT 3: REFLECTION & INSTITUTIONAL ANALYSIS (1 hour)

Objective: Critically examine your institution's consent practices.

Instructions: Answer the following reflection questions in 1-2 paragraphs each.

Reflection Question 1:

"How does my institution's informed consent process differ from the federal regulatory minimum (21 CFR Part 50)?"

Write about:

• What elements does your institution include beyond Part 50 minimum?
• What additional protections or best practices does your institution use?
• Examples: Lay-person review of forms, teach-back method, comprehension assessment, etc.

Your Response:

Reflection Question 2:

"What is the strongest aspect of my institution's consent process? What is one area needing improvement?"

Write about:

• One strength you've observed (clear language, accessible forms, good contact info, etc.)
• One area that could be better (technical jargon, missing elements, poor subject assessment, etc.)
• How would you recommend improving the weak area?

Your Response:

Reflection Question 3:

"In my role, how can I improve informed consent quality for the studies I support?"

Write about:

• Specific actions you can take
• Who you would collaborate with (IRB, investigators, coordinators, etc.)
• One pilot improvement you could advocate for

Your Response:

ASSIGNMENT 4: CONSENT FORM CREATION EXERCISE (1 hour)

Objective: Write Element 11 for a hypothetical study (practice including important design features).

Scenario: A study enrolls 50 subjects with Type 2 diabetes in a 24-week, randomized (1:1), placebo-controlled trial of an investigational oral medication. The trial will assess efficacy and safety. Subjects will provide blood samples at baseline and weeks 12 and 24; samples may be retained for future genetic studies. Subjects must maintain stable diabetes medications (no dose changes) during the study. Pregnancy is exclusionary.

Your Task: Write Element 11 ("Additional Material Information") for this study's consent form. Include all material design features not covered in Elements 1-10.

Element 11: Additional Material Information

Write here (minimum 150 words):

Self-Check: Did you include:

• Study duration (24 weeks)?
• Randomization (1:1 to placebo or drug)?
• Placebo possibility?
• Blood collection frequency & retention for future use?
• Medication stability requirement?
• Pregnancy exclusion?
• Any other material design features?

Sample Element 11 Answer:

"This is a randomized study, meaning you will be assigned by computer to receive either the study drug or placebo (an inactive pill). You will have a 50% chance of receiving the study drug and 50% chance of receiving placebo. You will not know which you receive until the study ends. This study will last 24 weeks and requires weekly clinic visits for the first 4 weeks, then monthly visits.

Blood will be drawn at study entry, week 12, and week 24. Your blood samples will be retained indefinitely for genetic research related to diabetes. You may request that your sample be destroyed at any time or may choose that samples NOT be used for future research. Results of genetic testing may be disclosed to you if you request, or withheld if you prefer.

During the study, you must keep your current diabetes medications and doses stable. Do not change medications without talking to Dr. Smith. This study cannot include pregnant women or women planning pregnancy. If you become pregnant during the study, you must notify us immediately.

Commercial development: If this study leads to a marketed product, you will not receive financial compensation or royalties."

ASSIGNMENT 5: HOMEWORK WRAP-UP QUIZ (30 minutes)

Final Check: Before the Week 2 Quiz, take this 10-question self-assessment.

Quick Quiz: Can You Answer These?

1. Name all 11 required elements without looking at notes.

   1. _____________________ 2. _____________________ 3. _____________________
   2. _____________________ 5. _____________________ 6. _____________________
   3. _____________________ 8. _____________________ 9. _____________________
   4. ____________________ 11. ____________________

2. What is exculpatory language? (1 sentence)

   ---

3. When can you skip informed consent? (Name the exception types)

   ---

4. Can a 10-year-old consent independently?

   ---

5. What must Element 11 contain?

   ---

6. Identify the violation: Form states "No compensation available" but doesn't explain who pays for injury treatment.

   Violation type: __________________________________________________________

7. Can a family member translate a consent form into Spanish for a non-English-speaking subject?

   ---

8. What does "minimal risk" mean?

   ---

9. Name one difference between 21 CFR Part 50 and ICH E6(R3).

   ---

10. How would you assess if informed consent is truly comprehended?

    ---

ANSWER KEY for Self-Assessment Quiz

1. Risks, Benefits, Alternatives, Confidentiality, Voluntary/Withdraw, Questions/Injury Contact, Compensation, FDA Contact, Costs, Termination, Additional Material Info

2. Language asking subject to waive legal rights (forbidden)

3. Waiver of consent (very rare, minimal risk only); Waiver of documentation (literacy/language barriers); Emergency exception (life-threatening, FDA approval required)

4. No. Parental consent required; child's assent encouraged if age/capable but not substitute

5. Any material information to the consent decision not covered in Elements 1-10 (design features, biobanking, duration, etc.)

6. Missing Element 7 (Compensation/Injury) - form needs to explain who pays for injury treatment

7. No. Qualified, independent interpreter required per best practice

8. Probability and magnitude of harm equal to everyday activities or routine medical care

9. Part 50 = regulation (must follow); E6(R3) = guidance (should follow); E6(R3) endorses risk-proportionate consent and eConsent

10. Use teach-back method: ask subject to explain back key points; assess understanding through discussion; provide extra time for questions

READING ASSIGNMENT FOR WEEK 3

Preparation for Next Week: 21 CFR Part 56 (IRBs)

Read and Annotate:

• 21 CFR 56.101-56.109 (Scope and definitions)
• 21 CFR 56.109 (IRB review criteria)

Annotation Prompts (mark in text):

1. Highlight the definition of "minimal risk"
2. Underline the three categories of IRB review (Exempt, Expedited, Full Board)
3. Mark any criteria that relate to informed consent requirements
4. Note how Part 56 and Part 50 overlap

Come to Week 3 class with 3 questions about Part 56 (write them down now)

Questions:

CHECKLIST

• Assignment 1 (Form Review) completed with all 11 elements assessed
• Assignment 2 (Violation Identification) completed with citations
• Assignment 3 (Reflection) answered thoroughly (3 questions)
• Assignment 4 (Element 11 Writing) includes all material features
• Assignment 5 (Self-Quiz) self-assessed (10 questions)
• Reading assignment completed and annotated (Part 56 preview)
• 3 Week 3 questions written down