Irb research ethics

IRB & Research Ethics

Purpose

Guide the learner through institutional review board (IRB) requirements, ethical design principles, and compliance with research regulations — ensuring human subjects are protected and the study meets institutional standards.

Key Concept: What Is IRB?

IRB = Institutional Review Board

• Regulatory body that reviews research involving human subjects
• Ensures compliance with federal regulations (45 CFR 46, The Common Rule)
• Protects research participants' rights, safety, and welfare
• Required by U.S. institutions receiving federal funding
• Most universities require IRB approval regardless of funding source

Process

Step 1 — Determine If You Need IRB Approval

Ask yourself:

1. Does my study involve human subjects? (Yes → likely needs IRB)
2. Do I collect data directly from people or their identifiable information? (Yes → likely needs IRB)
3. Is my research non-exempt? (Most dissertations are non-exempt → needs full review)

Common Exempt Categories (may not need approval):

• Archival research using de-identified/public documents
• Surveys of low-risk topics with no identifiable information
• Certain educational research practices
• Check with your IRB; do not self-determine exemption

Step 2 — Understand Your Ethical Obligations

The Belmont Report (3 Principles)

Principle	What It Means	Your Responsibility
Respect for Persons	Individuals are autonomous agents; protect those with diminished autonomy	Obtain informed consent; protect vulnerable populations
Beneficence	Maximize benefits; minimize harm	Design research that serves a meaningful purpose; mitigate risks
Justice	Fair distribution of research benefits & burdens	Don't over-burden vulnerable groups; ensure equitable participant selection

Core Ethical Considerations

• Informed Consent: Participants understand what they're agreeing to
• Minimization of Risk: Research procedures don't expose people to unnecessary harm
• Confidentiality & Privacy: Protect participant identities and data
• Data Security: Secure storage, access restrictions, secure deletion protocols
• Researcher Integrity: No deception (except where ethically justified & justified to IRB)

Step 3 — Draft Your IRB Protocol

Typical IRB Application Sections

1. Research Overview

   • Study title
   • Purpose & significance
   • Specific aims/hypotheses
   • Duration of study

2. Study Design & Procedures

   • Research methodology (qualitative, quantitative, mixed)
   • Participant recruitment (how many, where, who)
   • Data collection methods (interviews, surveys, observations, etc.)
   • Timeline
   • Clearly describe what participants will do step-by-step

3. Participant Population

   • Number of participants
   • Age range
   • Inclusion/exclusion criteria
   • Any vulnerable populations (minors, pregnant women, prisoners, cognitively impaired, etc.)

4. Informed Consent Form (ICF)

   • Study purpose & procedures
   • Time commitment
   • Risks & discomforts
   • Benefits (if any)
   • Confidentiality & data protection
   • Right to withdraw without penalty
   • Researcher contact info & IRB contact info
   • Must be written at 6th-8th grade reading level

5. Risk Assessment

   • Identify all risks (physical, psychological, social, financial, legal)
   • For each risk, explain how it will be minimized
   • Assess overall risk as minimal or greater than minimal
   • Example: "Risk of emotional discomfort during interviews about trauma; mitigation: offer breaks, provide counseling referrals"

6. Confidentiality & Data Protection

   • How you'll store data (encrypted drive, password-protected server, etc.)
   • Who has access to raw data
   • How long you'll retain data
   • De-identification procedures (coding, pseudonyms)
   • Data destruction plan
   • HIPAA/FERPA compliance (if applicable)

7. Compensation (if applicable)

   • Will you pay participants? How much?
   • When will they be paid?

8. Researcher Qualifications

   • Your training in human subjects research
   • Any prior IRB approvals
   • Your advisor's involvement/oversight

Step 4 — Special Populations & Enhanced Protections

Vulnerable Populations require additional ethical safeguards:

Population	Considerations	Protections
Minors (<18 years)	Cannot legally consent	Parental informed consent + child assent; minimize risk; clear benefits
Prisoners	At risk of coercion; limited autonomy	Minimize inducements; clear voluntary participation; neutral recruitment
Cognitively Impaired	Cannot consent independently	Legally authorized representative must consent; participant assent when possible
Pregnant Women	Potential fetal risk	Minimize risk; clear disclosure; additional safety monitoring
Students/Employees	Power dynamic with researcher	Use anonymous surveys; ensure no penalty for non-participation
Low Socioeconomic Status	May feel coerced by compensation	Reasonable compensation; no undue inducement
Non-English Speakers	Cannot fully consent without translation	Provide translated ICF & verbal explanation by interpreter

Step 5 — Draft Your Informed Consent Form

Required Components (per federal regulations):

1. Purpose & Procedures (Plain Language)

   • "This research is about understanding [topic]."
   • "If you participate, you will [describe what they do]."

2. Duration

   • "The study will take about [X] hours."

3. Risks & Discomforts

   • "Risks may include [list all potential harms, even minor ones]."
   • "We will [mitigation strategy]."

4. Benefits

   • Honest statement; don't overstate
   • "You may not benefit directly, but this research may help [future application]."

5. Confidentiality

   • "We will keep your responses confidential by [method]."
   • "Your data will be stored on [secure location]."
   • Limits to confidentiality (mandatory reporting, etc.)

6. Right to Withdraw

   • "You may withdraw at any time without penalty."
   • "Withdrawing will not affect your grade/employment/benefits."

7. Researcher Contact & IRB Contact

   • Your name, email, phone
   • Advisor name & contact
   • IRB office contact (usually provided by institution)

8. Voluntary Participation

   • "Your participation is voluntary."
   • "You are free to decline or skip questions."

Readability

• Use short sentences (15–20 words)
• Avoid jargon
• Test with 6th–8th grade reading level (Flesch-Kincaid)
• Use bullet points and white space

Step 6 — Data Security & Compliance

Security Plan Must Address

• Physical Security: Locked file cabinets for paper records
• Digital Security: Encrypted drives, password-protected accounts, two-factor authentication
• Access Control: Only you and advisor access raw data
• De-identification: Remove names, identifying info; use participant ID codes
• Data Retention: How long you'll keep data after study ends
• Destruction Plan: How/when you'll securely delete data

GDPR & Special Considerations (if recruiting internationally)

• Explicit consent for data processing
• Right to be forgotten (delete personal data on request)
• Data Processing Agreement if using third-party platforms

Step 7 — IRB Review Timeline & Process

Typical Timeline

• Submission → Initial review: 1–2 weeks
• IRB meeting: Monthly or biweekly
• Full board review: 2–4 weeks
• Revisions & resubmission: 1–2 weeks
• Total: 1–3 months from submission to approval

Your Role

1. Submit complete protocol + ICF to IRB office
2. Receive initial completeness check
3. Respond to IRB questions/requests for revision
4. Wait for full board meeting
5. Receive approval letter (sometimes with minor/major revisions)
6. Make revisions if requested; resubmit
7. Receive final approval; do not begin study until approved

Step 8 — Amendments & Ongoing Compliance

After Approval

• Protocol Amendment: Required if you change methods, add/remove participants, change compensation, recruit a new population, etc.
• Adverse Event Report: If a participant is injured or harmed
• Progress Reports: Most IRBs require annual renewal; submit brief update
• Closure Report: When study ends; submit final report

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IRB Prep Checklist

• Determine if study requires IRB approval (ask your advisor)
• Review your institution's IRB guidelines & forms
• Draft study design with clear participant procedures
• Identify any vulnerable populations
• Assess risks; develop mitigation strategies
• Draft Informed Consent Form at 6th–8th grade reading level
• Describe confidentiality & data security procedures
• Prepare researcher qualifications section
• Collect required institutional forms (protocol, compliance checklist, etc.)
• Get advisor review before IRB submission
• Submit complete application to IRB office
• Respond promptly to IRB requests for clarification
• Do not collect data until IRB approval is received

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Ethical Red Flags

🚩 Asking participants for identifying information but claiming confidentiality
🚩 Minimizing or omitting known risks from the ICF
🚩 Using coercion or undue inducement for participation
🚩 Working with minors or vulnerable populations without special protections
🚩 Inadequate data security measures
🚩 Collecting data before IRB approval

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Resources

• Your institution's IRB office website
• The Belmont Report (foundational ethics principles)
• CITI Program training (Collaborative Institutional Training Initiative; often required)
• Federal regulations: 45 CFR 46 (Common Rule)