Topic 1

Foundations of Research Ethics

Research ethics refers to the moral principles that guide the design, conduct, and reporting of research. These principles protect research participants, ensure scientific integrity, and maintain public trust in the research enterprise. Understanding research ethics is not optional—it is a fundamental responsibility of every researcher.

Why Research Ethics Matters

Protect Participants

Prevent physical, psychological, social, or economic harm to people involved in research

Maintain Trust

Public trust in science depends on ethical conduct; scandals erode confidence

Ensure Quality

Ethical research is good research—integrity leads to valid, reliable findings

Legal Compliance

Laws and regulations mandate ethical conduct; violations have serious consequences

Historical Context: Why We Have Ethics Regulations

Current ethics regulations arose from horrific research abuses. Understanding this history helps us appreciate why these protections exist.

Nazi Medical Experiments (1939-1945)

Nazi doctors conducted brutal experiments on concentration camp prisoners including freezing, high altitude, infectious disease, and surgical experiments without consent.

Outcome: Nuremberg Trials led to the Nuremberg Code (1947)—the first international document requiring voluntary informed consent.

Tuskegee Syphilis Study (1932-1972)

U.S. Public Health Service studied untreated syphilis in 399 Black men in Alabama. Participants were told they were receiving treatment but were actually given placebos. Even after penicillin became available (1947), treatment was withheld for decades.

Outcome: Exposed in 1972; led to the National Research Act (1974) and creation of Institutional Review Boards (IRBs).

Milgram Obedience Studies (1961)

Stanley Milgram deceived participants into believing they were administering painful electric shocks to others. Many participants experienced significant distress.

Outcome: Raised questions about deception in research and psychological harm; influenced development of debriefing requirements.

Stanford Prison Experiment (1971)

Philip Zimbardo assigned students to roles of "guards" and "prisoners." The study was terminated early due to psychological harm—guards became abusive, prisoners suffered emotional breakdowns.

Outcome: Highlighted need for monitoring studies and having clear stopping rules.

Willowbrook Hepatitis Study (1956-1970)

Researchers deliberately infected mentally disabled children with hepatitis at Willowbrook State School to study the disease. Parents were coerced into consent by making it a condition for admission.

Outcome: Raised concerns about vulnerable populations and coerced consent.

Key Ethical Documents and Principles

The Nuremberg Code (1947)

International

First international code of research ethics, establishing 10 principles:

  1. Voluntary consent is absolutely essential
  2. Research should yield fruitful results for society
  3. Research should be based on prior animal experimentation
  4. Avoid unnecessary physical and mental suffering
  5. No experiment where death/disability is expected
  6. Risk should not exceed humanitarian importance
  7. Proper preparations to protect against harm
  8. Only scientifically qualified persons should conduct research
  9. Subject can withdraw at any time
  10. Researcher must be prepared to stop if harm occurs

Declaration of Helsinki (1964, revised 2013)

World Medical Association

Ethical principles for medical research involving human subjects:

  • Participant welfare takes precedence over science/society
  • Independent ethics committee review required
  • Informed consent with right to withdraw
  • Special protections for vulnerable groups
  • Scientific validity is an ethical requirement
  • Results must be published (including negative results)

The Belmont Report (1979)

United States

Foundation of U.S. research ethics policy. Establishes three core principles:

Respect for Persons

Individuals should be treated as autonomous agents; persons with diminished autonomy deserve protection.

Application: Informed consent

Beneficence

Maximize benefits and minimize harms. "Do no harm" and actively promote well-being.

Application: Risk-benefit assessment

Justice

Fair distribution of research benefits and burdens. Don't exploit vulnerable groups for benefits enjoyed by others.

Application: Fair subject selection

Ethical Principles Applied

Principle Core Question Research Application
Respect for Persons Are participants making free, informed choices?
  • Informed consent process
  • Right to withdraw
  • Protecting those who cannot consent
Beneficence Do benefits outweigh risks?
  • Risk-benefit analysis
  • Minimizing harm
  • Maximizing benefits
  • Research design optimization
Justice Who bears the burdens and who receives the benefits?
  • Fair selection criteria
  • Including diverse populations
  • Not targeting vulnerable groups unfairly

Ethics is Not Just Rule-Following

Research ethics is about more than checking boxes on a form. It requires:

  • Genuine concern for participant welfare
  • Critical thinking about potential harms
  • Ongoing vigilance throughout the study
  • Willingness to prioritize ethics over convenience or results
Topic 2

Informed Consent

Informed consent is the cornerstone of ethical research. It ensures that participants voluntarily agree to participate after receiving clear, complete information about what the research involves. Consent must be a process, not just a signed form.

Informed Consent is the process by which a participant voluntarily confirms their willingness to participate in research after being fully informed of all relevant aspects of the study.

The Three Elements of Valid Consent

1

Information

Participants must receive complete, understandable information about:

  • Purpose of the research
  • Procedures involved
  • Duration of participation
  • Potential risks and discomforts
  • Potential benefits
  • Alternatives to participation
  • Confidentiality protections
  • Compensation (if any)
  • Contact information for questions
  • Statement that participation is voluntary
2

Comprehension

Information must be presented in a way participants can understand:

  • Language appropriate to education level (aim for 8th grade reading level)
  • Avoid jargon and technical terms
  • Provide in participant's native language
  • Allow time for questions
  • Confirm understanding (not just ask "do you understand?")
  • Consider literacy levels
3

Voluntariness

Consent must be given freely without coercion or undue influence:

  • No pressure or threats
  • No excessive incentives that cloud judgment
  • No exploitation of authority relationships
  • Right to withdraw at any time without penalty
  • No negative consequences for declining

Required Elements of Consent Form

Basic Required Elements

  • Statement that study involves research
  • Purpose and procedures explained
  • Duration of participation
  • Description of foreseeable risks
  • Description of potential benefits
  • Alternative procedures/treatments (if applicable)
  • Extent of confidentiality
  • Compensation and treatment for injury (if more than minimal risk)
  • Contact information for questions
  • Statement of voluntary participation and right to withdraw

Additional Elements (When Applicable)

  • Unforeseeable risks may exist
  • Circumstances for termination
  • Additional costs to participant
  • Consequences of withdrawing
  • New findings will be disclosed
  • Number of participants
  • Future use of data/specimens

Sample Consent Form Structure

Informed Consent Form Template

Study Title

"The Effect of Mindfulness Training on Student Stress Levels"

Principal Investigator

Dr. [Name], [Institution], [Contact Information]

Purpose of Study

"We are inviting you to participate in a research study examining whether mindfulness training helps reduce stress in college students. We hope to learn..."

What You Will Be Asked to Do

"If you agree to participate, you will be asked to:
• Complete a stress questionnaire (15 minutes)
• Attend 8 weekly mindfulness sessions (1 hour each)
• Complete follow-up questionnaires at 1 and 3 months
Total time commitment: approximately 12 hours over 4 months"

Risks and Discomforts

"Risks are minimal. You may experience temporary emotional discomfort when answering questions about stress. Some people may find meditation initially frustrating. If you experience distress, you can stop at any time."

Benefits

"You may benefit from learning mindfulness techniques that could help manage stress. Your participation will also contribute to scientific knowledge that may help other students in the future."

Confidentiality

"Your responses will be kept confidential. Data will be stored on password-protected computers. Your name will not be linked to your responses. Only the research team will have access to identified data."

Voluntary Participation

"Your participation is voluntary. You may refuse to participate or withdraw at any time without penalty. Your decision will not affect your grades or standing at the university."

Signature Section

"I have read and understood the above information. I have had the opportunity to ask questions and received satisfactory answers. I voluntarily agree to participate in this study."

Participant Signature: _____________ Date: _______
Researcher Signature: _____________ Date: _______

Special Consent Situations

Children and Minors

  • Parental permission required (consent from parent/guardian)
  • Child assent required when child can understand (typically age 7+)
  • Both are needed—parental consent alone is not enough
  • Assent form should be age-appropriate (simpler language)

Cognitively Impaired Individuals

  • Legally authorized representative provides consent
  • Participant provides assent to extent capable
  • Capacity to consent may vary over time
  • Extra protections required

Online Research

  • Electronic consent is acceptable
  • Click-through or electronic signature
  • Provide printable copy or link to full consent
  • Ensure participant has time to read
  • Verification methods for age/eligibility

Deception Research

  • Deception only when justified and approved by IRB
  • Must not be able to obtain data otherwise
  • Full debriefing after participation
  • Participants can withdraw data after learning true purpose
  • No deception about risks

Waiver of Written Consent

May be waived when:

  • Signature would be only link to identity (and study is minimal risk)
  • Research involves minimal risk only
  • Culture where signing documents is unusual
  • Verbal consent documented instead

Waiver of Consent (Entire)

Complete waiver may be granted when ALL of the following are true:

  • Research is minimal risk
  • Rights and welfare not adversely affected
  • Research cannot practicably be done with consent
  • Additional information provided afterward (if appropriate)

Example: Analysis of existing medical records where contacting thousands of patients is impractical

Common Consent Problems to Avoid

  • Exculpatory language: "By signing, you waive your legal rights"—NEVER allowed
  • Too technical: Using jargon participants won't understand
  • Too long: Overwhelming participants with pages of text
  • Rushing: Not allowing adequate time to read and ask questions
  • Power imbalance: Professor recruiting own students, doctor recruiting patients
  • Excessive incentives: Payments so high they constitute undue influence
Topic 3

Institutional Review & Approval

Institutional Review Boards (IRBs) in the U.S., or Ethics Committees in other countries, are responsible for reviewing and approving research involving human subjects. Their role is to protect participants and ensure research meets ethical standards before it begins.

Institutional Review Board (IRB) is an administrative body established to protect the rights and welfare of human research subjects. IRB review and approval is required before initiating most research involving humans.

IRB Review Categories

Exempt Review

Minimal Risk

Definition: Research that qualifies for exemption from full IRB review (but still requires IRB determination of exemption)

Common exempt categories:

  • Educational research on instructional strategies
  • Anonymous surveys with adults on non-sensitive topics
  • Observation of public behavior (no intervention, no identification)
  • Analysis of existing, de-identified data
  • Taste and food quality evaluations

NOT exempt if:

  • Includes children (usually)
  • Involves prisoners
  • Collects identifiable sensitive information
  • Deception is used

Timeline: Usually 1-2 weeks

Expedited Review

Minimal Risk

Definition: Minimal risk research reviewed by IRB chair or designated member (not full board)

Common expedited categories:

  • Collection of blood samples (limited amounts)
  • Non-invasive biological specimens (saliva, hair)
  • Voice/video recording for research purposes
  • Research on group behavior (focus groups)
  • Surveys with identifiable information
  • Minor changes to previously approved research

"Minimal risk" means: Probability and magnitude of harm are no greater than those ordinarily encountered in daily life or routine physical/psychological exams

Timeline: Usually 2-4 weeks

Full Board Review

More Than Minimal Risk

Definition: Research reviewed at a convened meeting of the full IRB (majority must be present, including non-scientific member)

Required for:

  • Greater than minimal risk research
  • Research with vulnerable populations (prisoners, pregnant women)
  • Clinical trials with experimental drugs/devices
  • Research involving significant deception
  • Studies where breach of confidentiality could harm participants

IRB must determine:

  • Risks are minimized
  • Risks are reasonable relative to benefits
  • Selection of subjects is equitable
  • Informed consent is adequate
  • Data monitoring plan is adequate (if needed)
  • Privacy and confidentiality protections are adequate

Timeline: 4-8 weeks or longer

The IRB Application Process

1

Complete Required Training

  • CITI (Collaborative Institutional Training Initiative) certification
  • Human Subjects Protection training
  • Additional training if working with specific populations
  • Usually valid for 3 years
2

Prepare Application Materials

  • Protocol description (purpose, methods, procedures)
  • Informed consent documents
  • Recruitment materials (flyers, emails, scripts)
  • Data collection instruments (surveys, interview guides)
  • Risk assessment
  • Data security plan
  • Personnel qualifications
3

Submit Application

  • Online submission system (varies by institution)
  • Ensure all documents are included
  • PI and faculty advisor must sign
4

IRB Review

  • Initial administrative review
  • Assigned to appropriate review category
  • Reviewer(s) examine protocol
  • May request clarifications or modifications
5

Response and Revision

  • Respond to all IRB queries
  • Revise documents as requested
  • Resubmit for additional review if needed
6

Approval

  • Receive approval letter
  • Note approval expiration date (usually 1 year)
  • DO NOT begin research until you have written approval!

Ongoing IRB Requirements

Continuing Review

Most studies require annual renewal before approval expires. Submit continuation application with progress report.

Amendments

Any changes to the approved protocol require IRB approval BEFORE implementation. This includes changes to consent forms, recruitment, procedures, or personnel.

Adverse Event Reporting

Report any unexpected problems, adverse events, or protocol deviations promptly. Serious events may require immediate reporting (within 24-48 hours).

Study Closure

When study is complete, submit closure report documenting enrollment numbers, any problems encountered, and data disposition.

Ethics Review Around the World

Region Review Body Key Regulations
United States Institutional Review Board (IRB) Common Rule (45 CFR 46), FDA regulations
European Union Research Ethics Committee (REC) GDPR, EU Clinical Trials Regulation
United Kingdom NHS Research Ethics Committee UK Policy Framework for Health and Social Care Research
Canada Research Ethics Board (REB) Tri-Council Policy Statement (TCPS2)
Australia Human Research Ethics Committee (HREC) National Statement on Ethical Conduct

Tips for Smooth IRB Approval

  • Start early—allow plenty of time for review
  • Review your institution's specific requirements and templates
  • Write clearly and avoid jargon
  • Be thorough in describing procedures and risks
  • Address how you'll handle potential problems
  • Consult with IRB staff before submitting if uncertain
  • Respond promptly and completely to reviewer queries
Topic 4

Protecting Participants

Protecting participants from harm is a fundamental ethical obligation. This includes minimizing physical, psychological, social, and economic risks; maintaining privacy and confidentiality; and providing special protections for vulnerable populations.

Types of Potential Harm

Physical Harm

Bodily injury, pain, illness, or physical side effects

Examples: Drug side effects, blood draws, physical procedures, fatigue from long sessions

Psychological Harm

Emotional distress, anxiety, depression, trauma

Examples: Recalling traumatic events, stress from testing, embarrassment, deception aftermath

Social Harm

Damage to relationships, reputation, or social standing

Examples: Stigma from disclosure of sensitive information, damaged relationships if participation is revealed

Economic Harm

Financial loss or damage to employment

Examples: Lost wages from participation, job loss if employer learns of sensitive information, loss of insurance

Legal Harm

Criminal liability or legal consequences

Examples: Disclosure of illegal activities, immigration status exposure

Privacy and Confidentiality

Privacy

Control over the extent to which personal information is shared

Focuses on: Access to the person

Example: Private interview location, not asking overly intrusive questions

Confidentiality

Treating data so that participants' identity is not revealed

Focuses on: Protection of data

Example: Secure storage, removing identifying information, limiting who sees data

Methods to Protect Confidentiality

Anonymous Data Collection

No identifying information collected at all. Strongest protection but limits follow-up.

Coding/De-identification

Replace names with ID codes. Store key separately with limited access.

Secure Storage

Password protection, encryption, locked file cabinets, limited access.

Data Aggregation

Report only group results, not individual responses.

Data Destruction

Destroy identifiers after study completion when no longer needed.

Certificates of Confidentiality

Legal protection (in U.S.) against compelled disclosure, even by subpoena.

Vulnerable Populations

Certain groups require additional protections because they may have diminished autonomy or be more susceptible to coercion or harm.

Children

Cannot legally provide consent

  • Parental permission required
  • Child assent when capable
  • Extra scrutiny of risk-benefit
  • Special categories under regulations

Prisoners

Constrained environment limits voluntary choice

  • Prisoner representative on IRB
  • Research must be relevant to prisoners
  • Participation not tied to parole
  • Extra protections against coercion

Pregnant Women

Risk to fetus must be considered

  • Risk to fetus minimized
  • Knowledge cannot be obtained otherwise
  • Father's consent if risk to fetus
  • No inducements for pregnancy termination

Cognitively Impaired

May not fully understand or appreciate research

  • Legally authorized representative
  • Ongoing assessment of capacity
  • Assent when possible
  • Benefits should flow to this group

Seriously Ill

Illness may impair judgment; may feel pressure to accept any treatment

  • Extra care in explaining alternatives
  • No therapeutic misconception
  • Ongoing consent as condition changes

Economically Disadvantaged

Payment may be unduly influential

  • Compensation reasonable, not coercive
  • Not targeted because easier to recruit
  • Benefits should flow to community

Students/Employees

Power imbalance may affect voluntariness

  • Not penalized for non-participation
  • Alternative ways to earn credit
  • Supervisor not involved in recruitment

Minimizing Risk: A Systematic Approach

1. Identify Risks

Systematically consider all potential harms—physical, psychological, social, economic, legal. Think about what could go wrong.

2. Assess Probability and Magnitude

How likely is each harm? How severe if it occurs? Focus on realistic, not hypothetical risks.

3. Minimize Risks

Reduce risks through study design, procedures, and safeguards. Can the information be obtained with less risk?

4. Weigh Benefits

Consider direct benefits to participants and knowledge benefits to society. Do benefits justify the risks?

5. Plan for Problems

Have protocols for handling adverse events. Provide referrals for distressed participants. Know when to stop the study.

Limits of Confidentiality

Participants should be informed that confidentiality may be broken when:

  • Child abuse or neglect is disclosed (mandatory reporting)
  • Participant is at imminent risk of harming self or others
  • Elder abuse is disclosed
  • Court order or subpoena (though Certificates of Confidentiality can protect against this)
Topic 5

Research Integrity & Misconduct

Research integrity means conducting and reporting research honestly and accurately. Research misconduct—fabrication, falsification, and plagiarism—undermines science and public trust. Understanding and avoiding misconduct is essential for every researcher.

The Three Forms of Research Misconduct

Fabrication

Serious Misconduct

Making up data or results and recording or reporting them

Examples:

  • Inventing data points that were never collected
  • Creating participants who never existed
  • Generating fake experimental results
  • Making up interview quotes

Consequences: Retraction, loss of funding, termination, debarment from federal funding, damaged reputation

Falsification

Serious Misconduct

Manipulating research materials, equipment, or processes, or changing or omitting data such that the research is not accurately represented

Examples:

  • Removing outliers without justification
  • Selectively reporting only favorable results
  • Changing images to remove inconvenient data
  • Altering statistical analyses to achieve significance
  • Misrepresenting methods used

Consequences: Same as fabrication

Plagiarism

Serious Misconduct

Appropriating another person's ideas, processes, results, or words without giving appropriate credit

Examples:

  • Copying text without quotation marks and citation
  • Paraphrasing too closely without citation
  • Using others' ideas without attribution
  • Self-plagiarism (reusing own work without disclosure)
  • Taking credit for others' analyses or methods

Consequences: Retraction, academic sanctions, reputational damage, degree revocation (for students)

Questionable Research Practices (QRPs)

Beyond formal misconduct, there are "gray area" practices that compromise research integrity even if not technically defined as misconduct.

HARKing

Hypothesizing After Results are Known

Presenting post-hoc hypotheses as if they were a priori

P-Hacking

Manipulating data analysis to achieve p < .05

Running many analyses and reporting only significant ones

Selective Reporting

Only reporting favorable results

Omitting null or negative findings

Inappropriate Authorship

Gift authorship (including those who didn't contribute)

Ghost authorship (excluding those who did contribute)

Inadequate Oversight

Not properly supervising students/staff

Not checking data quality

Duplicate Publication

Publishing same data in multiple journals

Without proper disclosure

Responsible Conduct of Research (RCR)

RCR encompasses all the practices that promote integrity and avoid misconduct.

Research Practices

  • Plan research carefully
  • Keep accurate, complete records
  • Report methods and results honestly
  • Acknowledge limitations
  • Share data appropriately

Authorship & Publication

  • Include all contributors as authors
  • Order authors fairly
  • Disclose conflicts of interest
  • Avoid duplicate publication
  • Cite sources properly

Data Management

  • Retain data for required period (often 5-7 years)
  • Store data securely
  • Share data when appropriate
  • Document data handling procedures

Collaborative Research

  • Clarify roles and responsibilities
  • Agree on authorship in advance
  • Communicate openly
  • Share credit appropriately

Mentoring

  • Train students in ethics
  • Model ethical behavior
  • Provide appropriate supervision
  • Support trainee development

Conflicts of Interest

  • Disclose financial interests
  • Manage personal relationships
  • Avoid situations that bias judgment
  • Recuse when appropriate

What to Do If You Suspect Misconduct

1. Document Your Concerns

Keep records of what you observed. Note dates, circumstances, and any evidence. Don't confront the individual directly or investigate yourself.

2. Consult Trusted Resources

Talk to a mentor, department chair, or research integrity officer. Many institutions have confidential reporting mechanisms.

3. Report Through Proper Channels

  • Research Integrity Officer
  • Institutional ombudsperson
  • Anonymous hotline (if available)
  • Federal agencies (ORI for NIH-funded research)

4. Whistleblower Protections

Federal regulations protect good-faith reporters from retaliation. Institutions must have policies protecting whistleblowers.

Building a Culture of Integrity

Research integrity is not just individual responsibility—it's institutional culture:

  • Model ethical behavior as mentors and leaders
  • Create environments where questions are welcomed
  • Reward quality over quantity
  • Take allegations seriously and investigate fairly
  • Provide ongoing ethics education

Notable Misconduct Cases

Diederik Stapel (Social Psychology, 2011)

Dutch social psychologist fabricated data in dozens of studies over years. 58+ papers retracted. Exposed fundamental problems in research oversight.

Hwang Woo-suk (Stem Cell Research, 2005)

South Korean scientist claimed breakthrough in human embryonic stem cells. Data was fabricated. Multiple papers retracted from top journals including Science.

Andrew Wakefield (Vaccines/Autism, 2010)

British doctor published fraudulent paper linking MMR vaccine to autism. Paper retracted, medical license revoked. Caused ongoing vaccine hesitancy.

Summary

Module 08 Key Takeaways

What You've Learned

  • Research ethics evolved from historical abuses—the Belmont Report's three principles (respect, beneficence, justice) guide ethical research
  • Informed consent requires information, comprehension, and voluntariness—it's a process, not just a form
  • IRB approval is required before research begins; review level depends on risk (exempt, expedited, full)
  • Protecting participants includes minimizing harm, maintaining confidentiality, and extra protections for vulnerable groups
  • Research misconduct (fabrication, falsification, plagiarism) has serious consequences; responsible conduct promotes integrity

Next Steps

In Module 09: Introduction to Data Analysis, you'll learn the fundamentals of organizing, preparing, and beginning to analyze your research data, including an introduction to descriptive statistics and data visualization.

Continue to Module 09
Practice

Ethics Practice Exercises

Applied Ethics Tasks

  1. Consent Form Development: Draft an informed consent form for a study on student smartphone use. Include all required elements.
  2. Case Analysis: For each scenario, identify ethical concerns and how you would address them:
    • A professor wants to use her own students as research participants
    • A researcher wants to observe people in a public park without consent
    • A study asks participants about illegal drug use
    • An employer wants to survey employees about job satisfaction
  3. Risk-Benefit Analysis: For a proposed study, list all potential risks, strategies to minimize them, and expected benefits. Make a recommendation about whether the study should proceed.
  4. IRB Preparation: Complete the ethics training (CITI or equivalent) at your institution if you haven't already.
  5. QRP Identification: Read a published research article and identify any potential questionable research practices or areas where you cannot assess whether practices were appropriate.
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