📘 Module 1
Why does ethics matter in research?
A tour through the principles that protect people and give science its legitimacy.
⚖️ The foundation of research ethics
Research ethics emerged from some of the darkest chapters in scientific history — the Nuremberg trials, the Tuskegee study, the case of Henrietta Lacks. These events revealed what happens when science ignores the humanity of its participants. Today, international frameworks exist to ensure that the pursuit of knowledge never overrides the rights and dignity of individuals.
Respect for persons
Individuals must be treated as autonomous agents. Those with diminished autonomy deserve special protection.
Beneficence
Maximize benefits and minimize possible harms. Research should do good — and avoid doing harm.
Justice
Benefits and burdens of research must be distributed fairly. No group should bear disproportionate risks.
Transparency
Honest reporting, open methods, and declared conflicts of interest are the bedrock of scientific trust.
📜 International framework
This course is grounded in the major international instruments:
- Nuremberg Code (1947) — First international code requiring voluntary consent
- Declaration of Helsinki (WMA, updated 2024) — Ethical principles for medical research with human participants
- Belmont Report (1979) — Three foundational principles: respect, beneficence, justice
- CIOMS Guidelines (2016) — International standards for health-related research
- ICMJE Recommendations (2024) — Standards for scholarly publication
- EU AI Act (2024) — First comprehensive AI regulation
1947 — Nuremberg Code
First international code on research ethics, born after the Nazi experiments trials.
1964 — Declaration of Helsinki
Ethical principles for medical research with human participants. Last revised in 2024.
1979 — Belmont Report
Establishes respect, beneficence, and justice as the three core principles.
2016 — CIOMS Guidelines
International ethical guidelines for health-related research involving humans.
2024–2026 — New challenges
AI Act, updated Helsinki, and the ethical challenges of artificial intelligence in research.
📗 Module 2
Research with human subjects
Protocol, risk levels, and researcher obligations under international standards.
📋 The research protocol
Before collecting any data, every study must have an approved protocol. According to the Declaration of Helsinki (Art. 22), the protocol must include:
- Title, objectives, and hypotheses
- Methodology and description of participants
- Recruitment and withdrawal procedures
- Risk description and mitigation measures
- Data protection plan
- Informed consent form(s)
- Data collection instruments
⚠️ Risk classification (Belmont / CIOMS)
| Category | Description | Examples |
|---|---|---|
| Minimal risk | Risk not greater than that in everyday life or routine examinations. | Anonymous surveys, document analysis, observation of public behavior. |
| Moderate risk | Procedures involving some discomfort or moderate psychological burden. | In-depth interviews, focus groups, sensitive topic questionnaires. |
| Greater than minimal | Significant probability of harm. Requires full ethics committee review. | Studies with vulnerable populations, minors, clinical interventions. |
🛡️ Vulnerable populations
- Minors: Require parental/guardian consent AND child assent.
- Dependent relationships: Teacher-student, supervisor-employee — consent must be obtained by an independent third party.
- People with disabilities: Specialized certification and legal representative.
- Marginalized communities: Prior community engagement and institutional approval.
✅ Researcher obligations
- Submit the protocol before starting the study.
- Report any adverse events to the ethics committee within 15 working days.
- Suspend immediately if harm to participants is detected (Helsinki, Art. 18).
- Submit a final report upon completion of the study.
- Retain signed consent forms in a secure location.
📙 Module 3
Informed consent
The agreement that guarantees autonomy and protects everyone involved.
📄 What is informed consent?
Informed consent is the free, voluntary, and documented agreement by which a participant authorizes their participation, with full knowledge of the objectives, procedures, benefits, and risks of the study.
The Declaration of Helsinki (Art. 25) states: "No person capable of giving informed consent may be included in a study unless they freely agree."
📋 Mandatory elements of informed consent
Justification and objectives of the research
Procedures to be used and their purpose
Foreseeable risks or discomforts
Expected benefits
Right to withdraw at any time without consequences
Confidentiality and data protection guarantee
Researcher and ethics committee contact information
Signature of participant (or legal representative) and two witnesses
💡 Check each element as you draft your consent form.
⚠️ Special situations
- Minors: Parental/guardian consent + child assent when maturity allows (Helsinki, Art. 29).
- Dependent relationships: Consent must be obtained by an independent third party.
- Minimal risk research: The ethics committee may authorize verbal consent with witnesses.
📕 Module 4
Publication & scientific integrity
Ethics doesn't end when data is collected — it continues through dissemination.
✍️ Responsible authorship (ICMJE 2024)
To be listed as an author, a person must:
- Have made substantial contributions to conception, design, data collection, or analysis.
- Drafted or critically revised the manuscript.
- Approved the final version.
- Agreed to be accountable for all aspects of the work.
Prohibited: honorary authorship (listing people who don't qualify) and ghost authorship (omitting people who do).
Fabrication
Inventing data, results, or references that never existed.
Falsification
Manipulating materials, data, or results to change their meaning.
Plagiarism
Presenting others' ideas, words, or data without proper credit.
Duplicate publication
Publishing the same work in multiple journals without disclosure.
🌐 Open science & FAIR data
- Publish negative results — not just positive ones (Helsinki, Art. 36).
- FAIR principles: Findable, Accessible, Interoperable, Reusable.
- Pre-registration: Register the study protocol before data collection.
- Open access: Share findings where anyone can read them.
🤖 Module 5
Artificial Intelligence in research
Opportunities, risks, and ethical obligations in the use of AI.
Why does AI require special ethical considerations?
AI systems in research can amplify biases, generate false results with the appearance of rigor, and raise new questions about authorship, privacy, and transparency that traditional frameworks did not anticipate.
🧾 AI in academic writing (ICMJE 2024)
- AI cannot be listed as an author — it cannot assume responsibility.
- Use of generative AI (ChatGPT, Copilot, etc.) in writing must be explicitly declared in the methods section.
- The researcher is responsible for all content accuracy, even if AI-assisted.
- Using AI to generate fake data, references, or results constitutes fabrication.
⚠️ Key risks in research
- Participant data: Entering identifiable participant data into AI platforms without consent violates privacy.
- Algorithmic bias: AI tools may reproduce gender, racial, or contextual biases.
- Hallucinations: Language models may generate false references with high apparent confidence.
- Methodological opacity: Undeclared AI use prevents reproducibility.
✅ Responsible AI practices
- Inform participants if AI will be used to analyze their responses.
- Verify every AI-generated reference before citing it.
- Do not enter identifiable participant data into AI tools without prior anonymization.
- Declare what AI tools were used, how, and for what purpose.
- Critically evaluate AI outputs: AI is a tool, not an arbiter of truth.
📝 Module 6
Final Assessment
Answer at least 7 out of 10 questions correctly to obtain your certificate.
1 According to the Declaration of Helsinki (2024), who is ultimately responsible for protecting research participants?
The ethics committee
The physician or researcher, not the participants themselves
The institution funding the research
2 Which of the following is NOT a criterion for authorship according to ICMJE?
Substantial contribution to data analysis
Approval of the final version of the manuscript
Being the head of department where the study was conducted
3 When there is a dependent relationship between researcher and participant, who should obtain informed consent?
The principal investigator
An independent third party not involved in that relationship
The ethics committee chair
4 What does "fabrication" mean in the context of research misconduct?
Presenting others' ideas without credit
Manipulating results to change their meaning
Inventing data or results that never existed
5 Can an AI system like ChatGPT be listed as an author of a scientific article?
No — AI cannot assume responsibility for the work
Yes, if it contributed significantly to the text
Only if the journal editor allows it
6 What do the FAIR principles stand for?
Findable, Accessible, Interoperable, Reusable
Free, Anonymized, Integrated, Reviewed
Factual, Auditable, Indexed, Reproducible
7 The principle of justice in research ethics requires that:
Researchers always publish their results
Benefits and burdens of research are distributed equitably
All participants receive the same treatment
8 When researching with minors, what documents are required?
Only the signature of the principal investigator
Only parental/guardian consent
Parental/guardian consent AND child assent
9 According to the Belmont Report, what are the three foundational principles of research ethics?
Consent, transparency, reproducibility
Respect for persons, beneficence, and justice
Autonomy, non-maleficence, fidelity
10 If a researcher detects harm to participants during a study, what must they do?
Document it and report at the end of the study
Suspend the research immediately
Consult with the director before deciding
0/10
correct answers
Dr. María del Pilar García-Chitiva
Short Training in Research Ethics
Certificate of Completion
This is to certify that
Participant Name
Research Ethics Course (REC)
Code:
Has successfully completed the 20-minute self-paced course on ethical principles,
research with human subjects, informed consent, publication integrity,
and responsible use of AI in research.
research with human subjects, informed consent, publication integrity,
and responsible use of AI in research.
Research Ethics Course · Dr. María del Pilar García-Chitiva · Integrity · Transparency · Responsibility
📁 Resources
Templates & documents
Download the official REC formats for your research.
📋 Research documents ✅ Direct download
Research Protocol Template
Official REC format · 10 sections · Includes ethics certification field
⬇ Download
Informed Consent Template
All mandatory elements per Declaration of Helsinki (2024) · With witness table
⬇ Download
Minor Assent Template (12–17 years)
Child-friendly language · Helsinki Art. 29 · Complements parental consent
⬇ Download
🔗 Key international references
- Declaration of Helsinki (WMA, 2024)
- Belmont Report (1979)
- CIOMS Guidelines (2016)
- ICMJE Recommendations (2024)
- COPE Core Practices (2024)
- EU AI Act (2024)
- FAIR Data Principles (Wilkinson et al., 2016)
📚 Further reading
Selected readings organized by topic.
📕 Book
Principles of Biomedical Ethics (8th ed.)
The foundational text of principlist bioethics. Develops the four principles with philosophical rigor and applied cases. Essential reading for anyone seeking to deepen their understanding of research ethics.
📄 Document
The Belmont Report
Foundational document establishing the three classic principles. Brief, accessible, and still fully relevant. Freely available online.
Access →
📄 Document
Declaration of Helsinki (2024 revision)
The international gold standard for research with human participants. The 2024 revision incorporates digital technology and emerging risk considerations.
Access →
📄 Document
CIOMS International Ethical Guidelines for Health-Related Research
Essential complement to Helsinki, with emphasis on research in low- and middle-income countries. Addresses consent, vulnerable communities, and equitable distribution of benefits.
Access →
📄 Document
ICMJE Recommendations (2024)
The gold standard for academic publication. The 2024 version includes updated guidance on generative AI, authorship, and conflicts of interest.
Download PDF →
📄 Resource
COPE Core Practices
Core practices for editors, reviewers, and authors. Includes guidelines on plagiarism, retractions, conflicts of interest, and peer review.
Access →
📕 Book
Ethics of Artificial Intelligence
Collection of philosophical essays on AI ethics: moral agency, responsibility, bias, and governance. Includes specific chapters on AI in health and education. One of the most rigorous and recent available.
📄 Regulation
EU AI Act — Regulation (EU) 2024/1689
The world's first comprehensive AI regulation. Classifies systems by risk level and sets obligations for providers and users. Essential reference for ethical use of AI in research.
Access →
📄 Article
The FAIR Guiding Principles for Scientific Data Management
Seminal article that defined FAIR principles (Findable, Accessible, Interoperable, Reusable) for ethical research data management. The standard reference in open science.
Access →
📄 Recommendation
UNESCO Recommendation on the Ethics of AI
Global framework of values and principles for ethical AI development and use, adopted by 193 countries. Includes considerations on research, education, and human rights.
Access →
Designed and created by
Dr. María del Pilar García-Chitiva
Research Ethics Course (REC) · 2026
Dr. María del Pilar García-Chitiva
Research Ethics Course (REC) · 2026