12  Research Ethics

Research ethics is the set of moral principles and professional standards that govern the conduct of research and the treatment of participants, data and findings. The candidate is expected to recognise the principles, the major forms of misconduct, the institutional checks (IRB, plagiarism regulations) and the international landmarks.

12.1 Core Principles of Research Ethics

TipFive Core Principles
Principle What it asks
Respect for persons / autonomy Treat participants as autonomous; protect those with diminished autonomy (children, prisoners, people with cognitive impairment)
Beneficence Maximise benefits, minimise harm
Non-maleficence Do no harm; avoid foreseeable risks
Justice Distribute benefits and burdens of research fairly
Integrity Honesty, transparency, accountability in conduct, reporting and peer review

These principles trace to the Belmont Report (1979) of the United States National Commission, which named respect for persons, beneficence, and justice as the foundational triad. The 1947 Nuremberg Code (after the Nuremberg trials) introduced the requirement of voluntary informed consent. The Declaration of Helsinki (1964, World Medical Association) extended the framework to medical research.

flowchart LR
  N[Nuremberg Code<br/>1947<br/>Voluntary informed consent] --> H[Declaration of Helsinki<br/>1964<br/>Medical research]
  H --> B[Belmont Report<br/>1979<br/>Respect · Beneficence · Justice]
  B --> C[CIOMS / WHO<br/>International ethical guidelines]
    classDef default fill:#003366,color:#ffffff,stroke:#ffcc00,stroke-width:3px,rx:10px,ry:10px;

12.3 Confidentiality, Anonymity, Privacy

TipThree Distinct Concepts
Concept What it means
Privacy Participant’s right to control access to themselves and their information
Anonymity The researcher cannot link the data to any identifiable individual — not even the researcher themself
Confidentiality The researcher knows the identity but undertakes not to disclose it

Anonymous data is, by construction, also confidential. Confidential data is not necessarily anonymous.

12.4 Forms of Research Misconduct

TipThe FFP Triad
Form What it does
Fabrication Making up data or results
Falsification Manipulating research materials, data or results to misrepresent the findings
Plagiarism Using another’s words, ideas or findings without proper credit
TipOther Forms of Misconduct
Form Description
Self-plagiarism / duplicate publication Republishing one’s own previously-published work without disclosure
Salami slicing Splitting one study into many small papers to inflate count
Gift / Guest authorship Including authors who did not contribute
Ghost authorship Excluding those who did contribute
HARKing Hypothesising After the Results are Known
p-hacking Repeatedly testing until a “significant” result appears
Cherry-picking Reporting only data that support the hypothesis
Conflict of interest, undisclosed Failing to disclose relationships that may bias the work
Image manipulation Editing figures to misrepresent findings

12.5 Plagiarism — Detail

TipTypes of Plagiarism
Type Description
Direct / Verbatim Copying word-for-word without citation
Mosaic / Patchwork Copying phrases from many sources and stitching them together
Paraphrasing without citation Rewriting another’s idea without crediting source
Self-plagiarism Reusing one’s own previously-published work without disclosure
Source-based Citing a non-existent source, or citing a secondary source as primary
Idea / Conceptual Using another’s concept or framework without credit

12.5.1 UGC Regulations on Plagiarism (2018)

The University Grants Commission notified the University Grants Commission (Promotion of Academic Integrity and Prevention of Plagiarism in Higher Educational Institutions) Regulations, 2018. The regulations classify similarity into four levels and prescribe progressive penalties for students.

TipUGC 2018 Plagiarism Levels — Students
Level Similarity Penalty for student
Level 0 Up to 10 % Minor similarities, no penalty
Level 1 Above 10 % up to 40 % Submit revised script within 6 months
Level 2 Above 40 % up to 60 % Debarred from submitting a revised script for 1 year
Level 3 Above 60 % Registration for that course / programme cancelled
TipUGC 2018 Plagiarism Levels — Faculty / Staff / Researchers
Level Similarity Indicative penalty
Level 1 10–40 % Withdraw the manuscript
Level 2 40–60 % Withdraw + denied annual increment for 1 year + barred from supervising for 2 years
Level 3 Above 60 % Withdraw + denied increment for 2 years + barred from supervising for 3 years
NoteDistractor warning

The 10 % “no penalty” threshold is a frequent NTA target. It refers to minor similarities such as references, common phrases and standard terminology, not copied text. The candidate should also note that quotations, references, generic terms and standard formulae are excluded from the calculation.

TipBodies Set Up by the UGC 2018 Regulations
Body Function
Departmental Academic Integrity Panel (DAIP) First-level body in the department
Institutional Academic Integrity Panel (IAIP) Institution-level body that confirms levels and prescribes penalties

12.6 Institutional Review and Ethics Committees

TipCommon Ethics-Review Bodies
Body Domain
Institutional Ethics Committee (IEC) Indian biomedical research; mandated by ICMR
Institutional Review Board (IRB) United States term; same function — approves research with human participants
Institutional Animal Ethics Committee (IAEC) Animal research; Indian regulator: CPCSEA
Institutional Biosafety Committee (IBSC) Recombinant DNA and biosafety research
Institutional Committee for Stem Cell Research (IC-SCR) Stem-cell-related work in India

The Indian Council of Medical Research (ICMR) issues National Ethical Guidelines for Biomedical and Health Research Involving Human Participants (most recent revision 2017).

12.7 Authorship Ethics

The International Committee of Medical Journal Editors (ICMJE) sets the most-used authorship criteria. ICMJE requires that all four conditions be met to qualify as an author:

  1. Substantial contribution to conception or design, or acquisition or analysis or interpretation.
  2. Drafting the work or revising it critically.
  3. Final approval of the version to be published.
  4. Accountability for all aspects of the work.
TipAuthorship — Right and Wrong Practices
  • Honorary authorship (head of department added without contribution) — wrong.
  • Ghost authorship (medical writer not credited) — wrong.
  • Corresponding author — the author who handles correspondence with the journal; usually also the senior author.
  • First author — typically the person who did most of the work.
  • Last author — in many fields, the senior PI who supervised the work.

12.8 Intellectual Property and Copyright

TipForms of Intellectual Property
Form What it protects Term in India
Copyright Original literary, artistic, dramatic, musical works; software Life + 60 years
Patent Inventions: products and processes that are new, useful, non-obvious 20 years from filing
Trademark Distinctive marks, logos, brand identifiers 10 years; renewable indefinitely
Industrial design Aesthetic shape and pattern 10 years; extendable to 15
Geographical indication (GI) Goods linked to a specific origin 10 years; renewable
Trade secret Confidential business information As long as kept secret

12.9 Animal Research, Vulnerable Populations, Biobanking

Special ethical attention is required for: children and adolescents, pregnant women, prisoners, people with cognitive impairment, indigenous communities, refugees, animal subjects, embryonic and stem-cell research, and human biological samples (biobanking).

12.10 Data Ethics

TipWorking Principles of Data Ethics
Principle What it asks
Lawful and fair processing Comply with the law (e.g., DPDP Act 2023 in India; GDPR in EU)
Purpose limitation Collect data only for stated, legitimate purposes
Data minimisation Collect only what is needed
Storage limitation Retain only as long as necessary
Integrity and confidentiality Protect against unauthorised access
FAIR principles Findable, Accessible, Interoperable, Reusable — for research data
Open data with consent Share where ethically permissible

12.11 Practice Questions

Q 01 Belmont Report Easy

The three foundational ethical principles named in the Belmont Report (1979) are:

  • AHonesty, Originality, Reliability
  • BRespect for persons, Beneficence, Justice
  • CValidity, Reliability, Practicability
  • DFabrication, Falsification, Plagiarism
View solution
Correct Option: B
The Belmont Report (1979) names Respect for persons, Beneficence, and Justice as the three foundational principles.
Q 02 FFP Triad Easy

Which of the following is not one of the FFP forms of research misconduct?

  • AFabrication
  • BFalsification
  • CPlagiarism
  • DPeer review
View solution
Correct Option: D
The FFP triad is Fabrication, Falsification, Plagiarism. Peer review is a quality-control mechanism, not misconduct.
Q 03 UGC Plagiarism Levels Medium

Under the UGC Plagiarism Regulations, 2018, similarity up to 10 % in a student's work is treated as:

  • ALevel 1 — submit revised script in 6 months
  • BLevel 2 — debarred for 1 year
  • CLevel 3 — registration cancelled
  • DLevel 0 — minor similarities; no penalty
View solution
Correct Option: D
Up to 10 % is Level 0 — minor similarities (references, common phrases, standard terminology); no penalty.
Q 04 International Landmarks Hard

Match the international landmark with its contribution:

(i) Nuremberg Code (1947) (a) Three principles — respect, beneficence, justice
(ii) Declaration of Helsinki (1964) (b) Voluntary informed consent
(iii) Belmont Report (1979) (c) Ethics for medical research
  • A(i)-(b), (ii)-(c), (iii)-(a)
  • B(i)-(a), (ii)-(b), (iii)-(c)
  • C(i)-(c), (ii)-(a), (iii)-(b)
  • D(i)-(b), (ii)-(a), (iii)-(c)
View solution
Correct Option: A
Nuremberg → consent; Helsinki → medical research; Belmont → three principles.
Q 05 Anonymity vs Confidentiality Medium

The difference between anonymity and confidentiality is that:

  • AAnonymity protects the researcher; confidentiality protects the participant
  • BAnonymity means the researcher cannot link data to any individual; confidentiality means the researcher knows the identity but agrees not to disclose it
  • CThe two terms are interchangeable in research ethics
  • DAnonymity applies only to children; confidentiality applies only to adults
View solution
Correct Option: B
Anonymity = no link possible. Confidentiality = link known but not disclosed.
Q 06 Self-Plagiarism Easy

Republishing one's own previously-published work without disclosure is called:

  • AFabrication
  • BSelf-plagiarism / duplicate publication
  • CCitation manipulation
  • DSalami slicing
View solution
Correct Option: B
Self-plagiarism / duplicate publication. (Salami slicing is a related but distinct practice — splitting one study into many small papers.)
Q 07 IRB / IEC Easy

Which body is responsible for ethical clearance of biomedical research involving human participants in an Indian institution?

  • AInstitutional Animal Ethics Committee (IAEC)
  • BInstitutional Ethics Committee (IEC) / Institutional Review Board (IRB)
  • CDepartmental Academic Integrity Panel (DAIP)
  • DNational Assessment and Accreditation Council (NAAC)
View solution
Correct Option: B
The IEC / IRB approves human-subjects research; IAEC handles animal research; DAIP handles plagiarism complaints.
Q 08 Patent Term Easy

Under Indian law, the term of protection for a patent is:

  • A10 years
  • B20 years from the date of filing
  • C60 years from the date of grant
  • DIndefinite, renewable
View solution
Correct Option: B
Patent protection in India runs 20 years from the date of filing. Copyright = life + 60; Trademark = 10 (renewable).
ImportantQuick recall
  • Five principles: Respect for persons, Beneficence, Non-maleficence, Justice, Integrity.
  • International landmarks: Nuremberg Code (1947) → Declaration of Helsinki (1964) → Belmont Report (1979).
  • Informed consent — four elements: Disclosure, Comprehension, Voluntariness, Competence.
  • Privacy ≠ Anonymity ≠ Confidentiality.
  • Misconduct: Fabrication, Falsification, Plagiarism (FFP); plus self-plagiarism, salami slicing, HARKing, p-hacking, gift/ghost authorship.
  • UGC Plagiarism Regulations 2018 — Levels 0/1/2/3 at 10/40/60 % thresholds.
  • DAIP (department-level) and IAIP (institution-level) bodies under UGC 2018.
  • Authorship: ICMJE four-criteria rule; corresponding / first / last author distinctions.
  • IPR terms (India): Copyright life + 60; Patent 20 from filing; Trademark 10 (renewable); Design 10 (extendable to 15).
  • FAIR data: Findable, Accessible, Interoperable, Reusable.