Research ethics

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Publication Ethics

World Medical Association Declaration of Helsinki (DoH)

Item 2013 text (current official) 2024-draft update* Practical take-home for researchers
Scope Medical research on humans, incl. identifiable data & material. Explicit inclusion of AI-derived data sets & decentralised trials. Anaesthetists using peri-operative registries must still apply DoH principles even if no direct intervention.
Scientific basis Research must be grounded in robust pre-clinical evidence & systematic review of literature. Same–plus mandatory trial registration before first patient. Register audits/quality-improvement studies if they test hypotheses.
Ethics review Independent Research Ethics Committee (REC/IRB) approval required. Adds REC competence clause & conflict-of-interest disclosure. South African studies: REC must be NHREC-registered (see §2).
Risk–Benefit Anticipated benefit must outweigh risks; constant re-assessment. Removes reference to “medical relevance” → stresses social value. Low-risk analgesic trials still need justification of burden (extra blood draws).
Vulnerable groups Extra justification & benefit for group. Specifies pregnant women & critically-ill as vulnerable. ICU anaesthesia studies: show direct benefit or minimal risk.
Post-trial access Participants should access interventions found beneficial. Draft proposes written post-trial care plan in protocol. Include how morphine pumps or devices will be supplied after study.
Compensation for harm Mandatory. Unchanged. SA requirement: proof of insurance attached to REC submission.
*Workgroup draft open for comment June 2024; final revision expected late 2025.

“Basic Ten”

  1. Voluntary, written, informed consent (or proxy + child assent).
  2. Valuable question–cannot be answered otherwise.
  3. Prior non-clinical/animal data.
  4. Minimise suffering.
  5. No expected death/disabling injury.
  6. Benefit › Risk, reviewed continuously.
  7. Adequate subject protection/insurance.
  8. Qualified investigators only.
  9. Subjects may withdraw anytime
  10. Investigators must stop the study if harm likely.

South-African Regulatory Framework for Health Research

Instrument Key points for exam Useful link
National Health Act 61/2003, s71 Any research involving humans needs written consent & NHREC-registered REC approval. Minors < 18 yr require parental permission + child assent if capable. doh.gov.za
HPCSA Booklet 13 (2023) Mirrors DoH; adds POPIA compliance, electronic consent guidance, & duty to publish negative results. hpcsa.co.za
NHREC Guidelines 2021 Risk categorisation: negligible, minimal, high; dictates expedited vs full review. nhrec.gov.za
ICH-GCP E6(R3) 2025 Major refresh–Quality-by-Design, risk-proportionate monitoring, electronic consent, decentralised trials. Applies to any investigational product trial.
SAHPRA Device/drug studies need SAHPRA AND REC approval; Section 21 for unregistered products. sahpra.org.za
  1. Study purpose, methodology & duration.
  2. Experimental status of interventions (placebo, randomisation, blinding).
  3. Expected benefits to participant / society.
  4. Foreseeable risks & discomforts; pregnancy precautions.
  5. Alternative treatments.
  6. Compensation, travel reimbursement & insurance cover.
  7. Confidentiality & data-sharing (POPIA, GDPR if EU data).
  8. Voluntary nature & right to withdraw without penalty.
  9. Post-trial care/benefit.
  10. Contact details for investigators & REC.
  • Special populations:
    • Children: written parental permission; age-appropriate assent; only if knowledge cannot be gained from adults.
    • ICU / incapacitated adults: deferred consent or proxy consent; REC must pre-approve plan; obtain delayed consent if capacity returns.

Plagiarism & Publication Ethics (COPE)

Type Definition Anaesthetic example Avoidance tip
Complete Submitting someone else’s paper. Copying a UK case-series on sugammadex into local journal. Turnitin check; journal similarity screening.
Direct / Verbatim Word-for-word copying. Lifting paragraphs from Miller’s Anesthesia into review article. Quote + cite, or paraphrase + cite.
Mosaic Patch-writing, mixing copied phrases. Combining snippets from five epidural RCTs. Rewrite in own words; keep notes.
Paraphrasing Slight re-wording without credit. Changing synonyms in another author’s abstract. Always reference original.
Source-based Fabricating or wrong citing. Citing a BJA paper that never showed stated result. Cross-check every citation.
Self-plagiarism / Salami Re-publishing own material or slicing one study into many papers. Two overlaps in “dexmedetomidine audit” conference abstracts. Declare prior dissemination; combine results.
Accidental Unintentional omission of citations. Student thesis chapter incorporated into journal ms. Keep meticulous reference library (Zotero, Mendeley).
  • COPE (Committee on Publication Ethics) flowcharts guide editors on investigations and retractions.

Links

References:

  1. Health Professions Council of South Africa (HPCSA). (2016). Guidelines for Good Practice in the Health Care Professions.
  2. World Medical Association. Declaration of Helsinki–Ethical Principles for Medical Research Involving Human Subjects (Oct 2013). wma.net
  3. World Medical Association. Declaration of Helsinki–2024 Workgroup Draft for Public Comment (June 2024). wma.net
  4. Health Professions Council of South Africa. General Ethical Guidelines for Health Researchers (Booklet 13). 2023. hpcsa.co.za
  5. National Health Research Ethics Council. Guidelines for Ethics Committees (2021).
  6. International Council for Harmonisation. ICH-GCP Guideline E6(R3) (Step 4, Jan 2025). database.ich.orgct-toolkit.ac.uk
  7. Committee on Publication Ethics (COPE). Guidance on Good Publication Practice (accessed 2025). publicationethics.orgpublicationethics.org
  8. SAHPRA. Clinical Trial Regulatory Framework (2024).
  9. Department of Health, South Africa. National Health Act 61 of 2003–s71.
  10. Shinde SS, Parak SC, Bhati S, Sahay N, Battu GS. Medico-legal and ethical issues in anaesthesiology profession. Indian J Anaesth. 2021 Jan;65(1):54-60. doi: 10.4103/ija.IJA_1476_20. Epub 2021 Jan 20. PMID: 33767504; PMCID: PMC7980236.

Summaries:

Copyright

© 2025 Francois Uys. All Rights Reserved.

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